protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04188379 | 7.3.1.5.2 | Pregnancies in Female Partners of Male Patients | 7.3.1.5.2. Pregnancies in Female Partners of Male Patients Male patients will be instructed through the ICF to immediately inform the investigator if their partner becomes pregnant during the trial or up to 90 days after they received the last IMP. A pregnancy report form should be completed by the investigator within ... | [] |
NCT04188379 | 7.3.2 | Clinical Laboratory Evaluations | 7.3.2. Clinical Laboratory Evaluations Blood and urine samples for determination of clinical chemistry, hematology, urinalysis, coagulation, thyroid, autoimmune antibody testing, FSH (only for women of nonchildbearing potential), PK, PD, antiplatelet antibodies, viral testing, tuberculosis QuantiFERON test, and ADA wil... | [] |
NCT04188379 | 7.3.3 | Vital Signs, Physical Examination, and Electrocardiogram | 7.3.3. Vital Signs, Physical Examination, and Electrocardiogram The assessment of vital signs (supine blood pressure, heart rate, and body temperature) physical examination, and ECG will be performed at the time points indicated in the SoA (Table 1). Supine blood pressure and heart rate will be measured using standard ... | [] |
NCT04188379 | 7.3.4 | Medical and Surgical History | 7.3.4. Medical and Surgical History All significant findings, surgeries, and pre-existing conditions present at screening must be reported on the relevant medical history/current medical conditions page of the eCRF, including start and end dates, if known. The date of ITP diagnosis as well as the date of confirmation o... | [] |
NCT04188379 | 7.3.5 | Data Safety Monitoring Board | 7.3.5. Data Safety Monitoring Board The sponsor will appoint an independent DSMB consisting of an independent group of clinical experts who are not involved in the trial management. They will be supplemented by an independent statistician. The objective of the DSMB will be to review all unblinded safety data (including... | [] |
NCT04188379 | 7.3.6 | Visit Reminder/Patient ID Card | 7.3.6. Visit Reminder/Patient ID Card Patients must be provided with the address and telephone number of the main contact for information about the clinical trial. The investigator must therefore provide a "Visit Reminder/Patient ID Card" to each patient. In an emergency situation this card serves to inform the respons... | [
"Pharmacokinetics",
"Pharmacodynamics",
"Anti-Drug Antibodies",
"Quality-of-Life and Patient-Reported Outcomes"
] |
NCT04188379 | 8 | STATISTICS | 8. STATISTICS The statistical analyses will be performed by the sponsor's designated CRO using statistical analysis systems SAS® (SAS Institute, Cary, NC, US) version 9.4 or higher, and the software package R, if applicable. The standard operating procedures (SOPs) and work instructions of the sponsor's designated CRO ... | [] |
NCT04188379 | 8.1 | Determinations of Sample Size | 8.1. Determinations of Sample Size The null and alternative hypotheses are defined as Ho: m1 = m2 vs. Ha: 71 # m2, where m1 and m are the population probabilities to achieve a sustained platelet count response (primary efficacy endpoint) for patients with chronic ITP receiving placebo and for patients with chronic ITP ... | [] |
NCT04188379 | 8.2 | Analysis Populations | 8.2. Analysis Populations The full analysis set (FAS) consists of all randomized patients. In general, the FAS will be used for efficacy analyses. For the primary and first key secondary endpoint the subset of all patients in the FAS with chronic ITP will be used. The analysis will follow the intent-to-treat principle,... | [
"Patient Disposition, Characteristics, and Concomitant Medication",
"Statistical Methods"
] |
NCT04188379 | 8.4.1 | Primary Endpoint Analysis | 8.4.1. Primary Endpoint Analysis
Definition of the estimand for the primary endpoint - x Population: adult patients with chronic ITP, having an average platelet count of <30×109 /L, and, at the start of the trial, either being on concurrent ITP treatment(s) and having received at least 1 prior therapy for ITP in the p... | [
"Definition of the estimand for the primary endpoint",
"Handling of main intercurrent events",
"Estimation of treatment effect and statistical inference",
"Handling of missing data",
"Complementary analyses"
] |
NCT04188379 | 8.4.2 | Key Secondary Endpoint Analyses Subject to Alpha Control | 8.4.2. Key Secondary Endpoint Analyses Subject to Alpha Control Extent of disease control is defined as the number of cumulative weeks over the planned 24-week treatment period with platelet counts of ≥50×109 /L. For each patient this number will be calculated by counting the number of analysis visits from week 1 until... | [] |
NCT04188379 | 8.4.3 | Other Secondary Endpoint Analyses Not Subject to Alpha Control | 8.4.3. Other Secondary Endpoint Analyses Not Subject to Alpha Control The secondary endpoints on overall platelet count response will be analyzed in the same manner as the primary endpoint. The secondary endpoint on extent of disease control will analyzed in the same manner as the corresponding key secondary endpoint. ... | [] |
NCT04188379 | 8.4.4 | Pharmacodynamics, Pharmacokinetics, and Immunogenicity | 8.4.4. Pharmacodynamics, Pharmacokinetics, and Immunogenicity Descriptive statistics will be provided for PD parameters (total IgG and subtypes, and antiplatelet antibodies) and ADA. Efgartigimod serum concentration data will be summarized. argenx BVBA Confidential Page 85 of 162 | [] |
NCT04188379 | 8.4.5 | Safety | 8.4.5. Safety Incidence and severity of AEs, AESIs, and SAEs will be summarized descriptively. Laboratory parameters, vital signs, and ECG data will also be analyzed descriptively. | [] |
NCT04188379 | 8.4.6 | Exploratory Endpoint Analysis | 8.4.6. Exploratory Endpoint Analysis 
Interim Analyses Not applicable. argenx BVBA Confidential Page 86 of 162 | [
"Interim Analyses"
] |
NCT04188379 | 9 | QUALITY CONTROL AND QUALITY ASSURANCE | 9. QUALITY CONTROL AND QUALITY ASSURANCE
Investigator's Responsibility The investigator will comply with the protocol which has been approved/given favorable opinion by the IRB/IEC, according to ICH Good Clinical Practice (GCP) and applicable regulatory requirements. The investigator is ultimately responsible for the ... | [
"Investigator's Responsibility",
"Quality Control",
"Monitoring",
"Data Management",
"Quality Assurance Audit"
] |
NCT04188379 | 10 | ETHICS | 10. ETHICS
Institutional Review Board or Independent Ethics Committee The investigator will provide the sponsor or designee with documentation of IRB/IEC approval of the protocol and informed consent documents before the trial may begin at the trial sites. The investigator will supply documentation to the sponsor or d... | [
"Institutional Review Board or Independent Ethics Committee",
"Ethical Conduct of the Trial",
"Patient Information and Informed Consent",
"Patient Data Protection"
] |
NCT04188379 | 11 | TRIAL ADMINISTRATION | 11.TRIAL ADMINISTRATION
Data Handling and Record Keeping It is the investigator's responsibility to maintain essential trial documents (records and documents pertaining to the conduct of this trial and the distribution of IMP, including regulatory documents, eCRFs, signed patient ICFs, laboratory test results, IMP inv... | [
"Data Handling and Record Keeping",
"Direct Access to Source Data/Documents",
"Investigator Information"
] |
NCT04188379 | 11.3.1 | Investigator Obligations | 11.3.1.Investigator Obligations This trial will be conducted by qualified investigators under the sponsorship of argenx BVBA (the sponsor). The name and telephone/fax numbers of the sponsor's designated CRO monitor and other contact personnel at the sponsor and the CRO are listed in the investigator trial file provided... | [] |
NCT04188379 | 11.3.2 | Protocol Signatures | 11.3.2. Protocol Signatures After reading the protocol, each investigator will sign the protocol signature page and send a copy of the signed page to the sponsor or representative. By signing the protocol, the investigator confirms in writing that he/she has read, understands, and will strictly adhere to the trial prot... | [] |
NCT04188379 | 11.3.3 | Publication Policy | 11.3.3. Publication Policy All information regarding efgartigimod supplied by the sponsor to the investigator and all data generated as a result of this trial, are considered confidential and remain the sole property of the sponsor. The results of the trial will be reported in a CTR. The CTR written in accordance with ... | [] |
NCT04188379 | 11.3.4 | Financing and Insurance | 11.3.4. Financing and Insurance The sponsor will fund the trial as outlined in the clinical trial agreement. The sponsor will obtain adequate global/local insurance for the trial participants including the trial patients for the required duration of time. The sponsor maintains an insurance coverage for this trial in ac... | [] |
NCT04188379 | 12 | REFERENCES | 12. REFERENCES - 1. Vaccaro C, Zhou J, Ober RJ, Ward ES. Engineering the Fc region of immunoglobulin G to modulate in vivo antibody levels. Nature biotechnology. 2005;23(10):1283. - 2. LPT31554. Laboratory of Pharmacology and Toxicology (LPT). 4-Week Subchronic Toxicity Study of ARGX-113 by Repeated 2-Hour Intravenous ... | [
"Appendix 1 Laboratory Evaluations",
"Appendix 2 Administrative Structure",
"Central Laboratories",
"Analysis of Pharmacokinetics, IgG Subtypes, and Anti-Drug Antibodies",
"Analysis of Total IgG",
"Antiplatelet Antibodies",
"(ADA), Antiplatelet Antibodies Samples Long-Term Storage of Pharmacokinetics-Ph... |
NCT04202679 | 1 | PROTOCOL SUMMARY | 1 PROTOCOL SUMMARY | [] |
NCT04202679 | 1.1 | SYNOPSIS | 1.1 SYNOPSIS Protocol title: A randomized, double blind, placebo-controlled, multi-center, parallel group study to evaluate the efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlled on topical prescription therapies or when those therapies are not advisable Short title: Stu... | [
"LIBERTY-PN PRIME2 (PRurigo Nodularis Itch Minimization Evaluation 2)",
"Rationale:",
"Objectives and endpoints",
"Overall design:",
"Number of participants:",
"Intervention groups and duration:",
"Duration of study period (per participant)",
"Study interventions",
"Dupilumab",
"Placebo",
"Stati... |
NCT04202679 | 1.2 | SCHEMA | 1.2 SCHEMA  EOS: end of study; EOT: end of treatment; PN: prurigo nodularis; Q2W: every 2 weeks; R: randomization; SC: subcutaneous; TCI: topical calcineurin inhibitors; TCS: topical corticosteroids. | [] |
NCT04202679 | 1.3 | SCHEDULE OF ACTIVITIES (SOA) | 1.3 SCHEDULE OF ACTIVITIES (SOA) | | Screening | Intervention period(Weeks) | | | | | | Notes | | |---------------------------------------|--------------------------------------|--------------------------------|---|---|----|-----------------|----------------------------|-------------------------------------------------... | [
"Amended Clinical Trial Protocol 01 EFC16460 - dupilumab"
] |
NCT04202679 | 2 | INTRODUCTION | 2 INTRODUCTION Dupilumab is a human monoclonal IgG4 antibody that inhibits IL-4 and IL-13 signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blo... | [] |
NCT04202679 | 2.1 | STUDY RATIONALE | 2.1 STUDY RATIONALE Prurigo nodularis is a skin disease characterized by multiple, intensely itchy skin eruptions in symmetrically distributed areas of the extremities [\(1\)](#page-103-1). It is difficult to treat and entails a high disease burden. Dupilumab has shown efficacy in multiple diseases with underlying Type... | [] |
NCT04202679 | 2.2 | BACKGROUND | 2.2 BACKGROUND Prurigo nodularis is a skin disease characterized by multiple, intensely itchy skin eruptions in symmetrically distributed areas of the extremities [\(1\)](#page-103-1). The main symptom is prolonged, repetitive and uncontrollable rubbing, scratching and uncontrollable itching which leads to hyperkeratot... | [] |
NCT04202679 | 2.3 | BENEFIT/RISK ASSESSMENT | 2.3 BENEFIT/RISK ASSESSMENT Dupilumab solution for injection is currently authorized: • In over 40 countries worldwide including the US, European Union (EU) (Centralised Procedure), and Japan for the treatment of adults with inadequately controlled moderate-to-severe AD. In the US and EU, it has also been authorized fo... | [] |
NCT04202679 | 3 | OBJECTIVES AND ENDPOINTS | 3 OBJECTIVES AND ENDPOINTS Table 1 - Objectives and endpoints | Objectives | Endpoints | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------... | [] |
NCT04202679 | 3.1 | APPROPRIATENESS OF MEASUREMENTS | 3.1 APPROPRIATENESS OF MEASUREMENTS The study endpoints will include both assessments of itch and assessments of the PN lesions. As discussed in [Section](#page-22-2) [2.2,](#page-22-2) the severe itch observed in this disease, the fact that lesions are typically observed in areas that are within reach for scratching, ... | [] |
NCT04202679 | 4 | STUDY DESIGN | 4 STUDY DESIGN | [] |
NCT04202679 | 4.1 | OVERALL DESIGN | 4.1 OVERALL DESIGN This study is a multi-center, 24-week treatment, parallel, double-blind, randomized, placebo-controlled study to evaluate the use of dupilumab in patients with PN inadequately controlled on topical prescription therapies or when those therapies are not advisable. The study will assess the effect of d... | [] |
NCT04202679 | 4.2 | SCIENTIFIC RATIONALE FOR STUDY DESIGN | 4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN This study is a multi-center, 24-week treatment, double-blind, randomized, placebo-controlled study to evaluate the use of dupilumab in patients with PN inadequately controlled on topical prescription therapies or when those therapies are not advisable. Based on mechanistic dat... | [] |
NCT04202679 | 4.3 | JUSTIFICATION FOR DOSE | 4.3 JUSTIFICATION FOR DOSE The selected dosing regimen is dupilumab 300 mg Q2W with a loading dose of 600 mg. This dose regimen is expected to achieve serum concentrations that saturate the target-mediated clearance pathway rapidly with the loading dose and maintain saturation thereafter. The PK of dupilumab is consist... | [] |
NCT04202679 | 4.4 | END OF STUDY DEFINITION | 4.4 END OF STUDY DEFINITION A participant is considered to have completed the study if he/she has completed all phases of the study including the last visit. The end of the study is defined as the date of the last visit of the last participant in the study. | [] |
NCT04202679 | 5 | STUDY POPULATION | 5 STUDY POPULATION Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT04202679 | 5.1 | INCLUSION CRITERIA | 5.1 INCLUSION CRITERIA Participants are eligible to be included in the study only if all of the following criteria apply:
Age I 01. Participants must be 18 to 80 years of age, at the time of signing the informed consent.
Type of participant and disease characteristics Patients with a clinical diagnosis of PN, as defi... | [
"Age",
"Type of participant and disease characteristics",
"Sex"
] |
NCT04202679 | I | 08. Male or Female | I 08. Male or Female Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - a) Female participants - A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the foll... | [
"OR",
"Informed Consent",
"5.2 EXCLUSION CRITERIA",
"Medical conditions",
"Prior/concomitant therapy",
"Prior/concurrent clinical study experience",
"Diagnostic assessments",
"Other exclusions",
"5.3 LIFESTYLE CONSIDERATIONS",
"5.4 SCREEN FAILURES",
"6 STUDY INTERVENTION",
"6.1 STUDY INTERVENT... |
NCT04242446 | A | PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN STUDY PARTICIPANTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA This document cannot be used to support any marketing authorization | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN STUDY PARTICIPANTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA This document cannot be used to support any marketing authorization
PROTOCOL HS0003 AMENDMENT 5
PHASE 3
SHORT TITLE: A Ph... | [
"PROTOCOL HS0003 AMENDMENT 5",
"PHASE 3",
"SHORT TITLE:",
"Regulatory agency identifying numbers:",
"Confidential Material",
"Confidential",
"PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE",
"SERIOUS ADVERSE EVENT REPORTING",
"Amendment 5 (27 Sep 2022)",
"Overall rationale for the amendment",
"1 PR... |
NCT04242446 | A | SAE is defined as any untoward medical occurrence that, at any dose: | A SAE is defined as any untoward medical occurrence that, at any dose:
a. Results in death
b. Is life-threatening The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically mi... | [
"a. Results in death",
"b. Is life-threatening",
"c. Requires inpatient hospitalization or prolongation of existing hospitalization",
"d. Results in persistent disability/incapacity",
"e. Is a congenital anomaly/birth defect",
"f. Important medical events:",
"Recording and Follow-Up of AE and/or SAE",
... |
NCT04327271 | 2 | PROJECT SUMMARY | 2. PROJECT SUMMARY Because male circumcision (MC) reduces the risk of female-to-male HIV-1 transmission by up to 60%, nearly 10.4 million voluntary medical male circumcision (VMMC) procedures were performed in sub-Saharan Africa where the HIV epidemic is most concentrated. VMMC is safe: the average rate of moderate and... | [] |
NCT04327271 | 3 | STUDY BACKGROUND, PURPOSE AND SUMMARY | 3. STUDY BACKGROUND, PURPOSE AND SUMMARY Male circumcision (MC) reduces the risk of female-to-male HIV-1 transmission by up to 60% 1-3 . From 2008-2017, over 15 million voluntary medical male circumcision (VMMC) procedures were performed4,5 , falling far short of the 20 million needed to reach the UNAIDS/ World Health ... | [] |
NCT04327271 | 4 | GOAL AND OBJECTIVES | 4. GOAL AND OBJECTIVES We propose to maintain patient safety while reducing the substantial VMMC follow-up workload burden by using two-way mobile phone texts to provide in-person review only for men who indicate a desire or need for follow-up. This tailored approach to post-procedure VMMC care could reduce unnecessary... | [] |
NCT04327271 | 5 | STUDY DESIGN | 5. STUDY DESIGN Study overview: Following usability testing with both healthcare workers and 2wT VMMC clients during a ~50-man pilot, we will test if two-way texting (2wT) reduces unnecessary follow-up visits without compromising patient safety (Objective 1) using a randomized control trial in large, urban VMMC clinics... | [
"RECRUITMENT SITES:",
"RECRUITMENT: PROCEDURE",
"Exclusion criteria:"
] |
NCT04327271 | 6 | STUDY PROCEDURES: | 6. STUDY PROCEDURES: PARTICIPANT OVERVIEW: - ● Based on prior experience in Zimbabwe, up to 50 men will be needed for the pilot depending to reach maximum system stability (after making adaptations) and to reach healthcare worker efficiency and comfort. This increases the quality of the full study. Not randomized. Enro... | [
"RANDOMIZATION PROCESS:",
"PARTICIPANT ELIGIBILITY AND RECRUITMENT:"
] |
NCT04327271 | 7 | TRAINING OF STUDY PERSONNEL: | 7. TRAINING OF STUDY PERSONNEL: VMMC staff at Aurum Institute study sites will be informed of the study and briefed on study protocols. A 2wT study coordinator will be trained in confidentiality, protection of human subjects, enrollment, and data collection methods, working to not interfere with routine VMMC flow. For ... | [] |
NCT04327271 | 8 | STUDY PARTICIPANTS: | 8. STUDY PARTICIPANTS: | Groupname/description | Datacollectionmethod | Agerangeofsubjects | Targetnumberofindividuals | |---------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------|-------------------... | [] |
NCT04327271 | 9 | DATA COLLECTION: | 9. DATA COLLECTION: Sample size: | [] |
NCT04327271 | 10 | DATA ANALYSIS: | 10. DATA ANALYSIS: For Objective 1, the 2wT safety outcome of interest is cumulative AE rate (moderate or severe) ≤ Day 14. In RSA, and similar to other countries in the region, moderate AEs are those which include symptoms requiring modification of activity, but not resulting in loss of work or cancellation of social ... | [] |
NCT04327271 | 11 | INFORMATION MANAGEMENT AND ANALYSIS SOFTWARE | 11. INFORMATION MANAGEMENT AND ANALYSIS SOFTWARE During informed consent, participants will be asked to give permission to use data from their routine VMMC medical records, including the VMMC register and client record form (CRF). Data from paper CIFs includes VMMC number, age, circumcision type, eligibility criteria, ... | [
"CAPACITY BUILDING AND SUSTAINABILITY:",
"FUTURE PLANS:",
"INNOVATIONS"
] |
NCT04327271 | 12 | ETHICAL CONDUCT OF THE STUDY | 12. ETHICAL CONDUCT OF THE STUDY This study will be conducted in compliance with the protocol after approval by the CDC, the Human Science Research Council Research Ethics Committee (REC), and the University of Washington IRB. No deviations from the protocol after approval will be implemented without prior approved ame... | [] |
NCT04327271 | 13 | CONFIDENTIALITY: | 13. CONFIDENTIALITY: Patients' routine VMMC data from VMMC registers and client record forms will be examined to extract data on patient demographics, clinical characteristics at baseline and during follow-up period, VMMC procedure notes, and adverse events reporting. This data will be entered into the study-specific d... | [] |
NCT04327271 | 14 | CONSENT | 14. CONSENT Subject recruitment and consent will be in English and Zulu (forthcoming based on comments on English version). All staff are fluent in both English and local languages for translation and transcription of activity materials. Consent forms, advertisements, and study information materials will be translated ... | [
"COMPENSATION FOR TIME:"
] |
NCT04327271 | 15 | DATA MANAGEMENT PLAN (DMP): | 15. DATA MANAGEMENT PLAN (DMP): A. We will develop a Data Monitoring Plan (DMP). The DMP will include a list of included data from routine, paper-based VMMC sources: Register, and client reporting forms (CRFs); study-specific data from the texting database; routine AE reports. We will establish best practices for colle... | [] |
NCT04327271 | 16 | LIMITATIONS AND UNCERTAINTIES: | 16. LIMITATIONS AND UNCERTAINTIES: Men undergoing device VMMC are excluded, limiting generalizability to surgical VMMC. Phone ownership in RSA's urban areas is high, but there is a small possibility that the population who undergoes VMMC has lower than estimated phone access, reducing the potential efficiency of a text... | [] |
NCT04327271 | 17 | INTENDED USE OF FINDINGS | 17. INTENDED USE OF FINDINGS This project will evaluate the effectiveness, feasibility, and acceptability of a promising intervention to improve VMMC efficiency while maintaining patient safety. If successful, both providers and patients would neither perform nor attend unnecessary visits, providing distinct advantages... | [] |
NCT04327271 | 18 | STUDY TIMELINE | 18. STUDY TIMELINE We expect the study to start immediately after the IRB approvals, technology adaptation, and pilot-driven modification. We aim to complete recruitment by June, 2021 in order to compete primary data analysis in July 2021. Objectives 2 and 3, as well as much of the statistical analyses will be conducte... | [] |
NCT04327271 | 19 | BUDGET | 19. BUDGET This project will cost approximately \$500,000. | [] |
NCT04327271 | 20 | REFERENCES | 20. REFERENCES - 1. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. The Lancet. 2007;369(9562):657-666. - 2. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. La... | [
"APPENDICES:"
] |
NCT04330040 | L1 | Schedule of Activities (S0A) | L1 Schedule of Activities (S0A)
Screening Phasc (Visit 1) Subjects, or their legally acceptable representative, will provide written informed consent before any trial-specific procedures are performed. During the Sercening Phase, eligibility criteria will be reviewed, and a complete clinical ovaluation will be perform... | [
"Screening Phasc (Visit 1)",
"'Treatment Phase(Visit 2-7)",
"End- reatment Visit (EOT; Visit 8)",
"Follow - Up Phase (End — Of- Study; Visit 9)",
"Footnotes:",
"Objectives and Endpoi",
"2. INTRODUCTION",
"21 Background and study rationale",
"To assess the safety of olaparib in Indian Number, frequen... |
NCT04330040 | 531 | Meals and dietary restrictions | 531 Meals and dietary restrictions No specific dietary restrictions will be imposed on subjects recruited for this study. Coadministration with food slowed the rate of absorption but did not siguificantly affect the extent of absorption of olaperib. Consequently, patients should take Lynparza without regar to food. 532... | [] |
NCT04330040 | 533 | Activity | 533 Activity There are no specific restr ns that will apply.
54 Screen failures Sercen failures are defined as subjects who signed the informed consent form o participate in the clinical study but are not subsequently entered in the study. A minimal set of sercen failure information i required to cnsure transparent re... | [
"54 Screen failures",
"6.1.1 Study Drug",
"Table 4 Study Drug particulars",
"6.2 Preparation/handling/storage/accountability",
"6.5.1 Other concomitant treatment",
"Medications that may NO'T be administered",
"Restricted concomitant medications",
"P-gp inhibitors",
"Anticoagulant Therapy",
"Anti-e... |
NCT04330040 | 835 | Causality collection | 835 Causality collection 'The Tovestigator will sscss causal relationship between study drug and each Adverse Event, ad answer 'yes" or \no' 1o the question 'Do you consider that there is a reasonable possibility that the event may have been caused by the study drug?" For SAEs, causel relationship will also be assessed... | [] |
NCT04330040 | 844 | Medication error | 844 Medication error Ifa medication error occurs in the coursc of the study, then the Investigator or other site personnel informs the appropriate AstraZencea representatives within | day ie., immediately but no later than 24 hours of when he or she becomes aware of it 'The designated AstraZeneca representative works w... | [] |
NCT04330040 | 845 | Management of study drug - related toxicities, duse interruptions and dose reductions | 845 Management of study drug - related toxicities, duse interruptions and dose reductions Toxicity observed during the course of the study could be managed by interruption of the dose of study treatment or dose reductions. Repeat dose interruptions are allowed as required, for & masimum of4 weeks o each occasion. If th... | [] |
NCT04330040 | 8451 | Management of hacmatological toxicity | 8451 Management of hacmatological toxicity
Munagement of anaemia Table7 Munagement of Anaemia | | Hb 8 g Give appropriats supportive treatment and investigatc causaliy.Investigator judgementcontinvewithsupportiveofaparibtotreatment (eg ensfusion) or interrupt dosc for a maximum of 4weeks. | | | | | | |----------------... | [
"Munagement of anaemia",
"8.4.5.2 Management of nentropenia, leukopenia and thrombocytopenia"
] |
NCT04330040 | 8453 | Management of prolonged hematological toxicities while on study treatment | 8453 Management of prolonged hematological toxicities while on study treatment 1f subject develops prolonged haematologieal toxicity such as: - 22 weeks interruption/delay in study treatment due to CTC grade 3 or worse sngemia and/or development of blood transfusion dependence 22 wecks interruption/delay in study treat... | [
"8.4.6.2 Management of nausea and vomiting",
"861 Collection of samples 87 Genetics",
"89 Medical Resource Utilization and Health Economics",
"9.1 Statistical hypotheses",
"9.3 Populations for analyses",
"9.4 Statistical analyses",
"943 Other analyses",
"95 Interim analyses",
"11. SUPPORTING DOCUMEN... |
NCT04332991 | 1 | STUDY SUMMARY | 1. STUDY SUMMARY | Title | Hydroxychloroquine for the Early Treatment of COVID-19 in Hospitalized | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Adults: A Multicenter Randomized C... | [
"• Symptomatic hypoglycemia • Neutropenia, lymphopenia, anemia, or thrombocytopenia • Severe dermatologic reaction Analysis The primary analysis will be an intention-to-treat comparison of the primary outcome between patients randomized to hydroxychloroquine versus placebo using a proportional odds model. An odds r... |
NCT04332991 | 2 | TRIAL DESCRIPTION | 2. TRIAL DESCRIPTION | [] |
NCT04332991 | 2.1 | Background | 2.1 Background Coronavirus Disease 2019 (COVID-19) is an acute respiratory infectious illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1,2 Although the epidemiology has not been fully elucidated, most adults with COVID-19 appear to experience fever, cough, and fatigue and then recover with... | [] |
NCT04332991 | 2.1.1 | COVID-19 Infection | 2.1.1 COVID-19 Infection COVID-19 was first identified as a cluster of cases of pneumonia among a group of workers from a seafood wholesale market in Wuhan, China in December 2019.7 This observation, along with subsequent viral genotyping showing significant genetic similarities to the bat coronaviruses8 suggest a zoon... | [] |
NCT04332991 | 2.1.2 | Hydroxychloroquine as a Therapeutic for COVID-19 | 2.1.2 Hydroxychloroquine as a Therapeutic for COVID-19 Hydroxychloroquine is a medication approved by the US Food and Drug Administration and accounts for millions of US prescriptions annually. It is used both as an antiparasitic agent for malaria and an immunomodulatory agent for rheumatologic diseases. When used for ... | [] |
NCT04332991 | 2.1.3 | Rationale for a Randomized Trial among Hospitalized Patients | 2.1.3 Rationale for a Randomized Trial among Hospitalized Patients The initial symptoms of COVID-19 develop approximately 2-10 days after infection with the SARS-CoV-2 virus,23 with the progression to respiratory failure and ARDS occurring approximately 7-10 days after the onset of symptoms.24 While most adults with CO... | [] |
NCT04332991 | 2.1.4 | Rationale for Evaluating Hydroxychloroquine Monotherapy | 2.1.4. Rationale for Evaluating Hydroxychloroquine Monotherapy In addition to hydroxychloroquine, several other medications have been proposed as potential therapies for COVID-19, including remdesivir and azithromycin. Remdesivir treatment for COVID-19 is being studied in a clinical trial sponsored by the National Inst... | [] |
NCT04332991 | 2.2 | Study Aims | 2.2 Study Aims | [] |
NCT04332991 | 2.2.1 | Study aim | 2.2.1 Study aim To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization. | [] |
NCT04332991 | 2.2.2 | Study hypothesis | 2.2.2 Study hypothesis Among adults hospitalized with COVID-19, administration of hydroxychloroquine will improve clinical outcomes at Day 15. | [] |
NCT04332991 | 2.3 | Study Design | 2.3 Study Design We will conduct an investigator-initiated, multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment. | [] |
NCT04332991 | 3 | STUDY POPULATION AND ENROLLMENT | 3. STUDY POPULATION AND ENROLLMENT | [] |
NCT04332991 | 3.1 | Inclusion Criteria | 3.1 Inclusion Criteria - 1. Age ≥18 years - 2. Currently hospitalized or in an emergency department with anticipated hospitalization. - 3. Symptoms of acute respiratory infection, defined as one or more of the following: - a. Cough - b. fever (> 37.5° C / 99.5° F) - c. shortness of breath (operationalized as any of the... | [] |
NCT04332991 | 3.2 | Exclusion Criteria | 3.2 Exclusion Criteria - 1. Prisoner - 2. Pregnancy - 3. Breast feeding - 4. Unable to randomize within 10 days after onset of acute respiratory infection symptoms - 5. Unable to randomize within 48 hours after hospital arrival - 6. Seizure disorder - 7. Porphyria cutanea tarda - 8. QTc >500 ms on electrocardiogram wit... | [] |
NCT04332991 | 3.3 | Justification of Exclusion Criteria | 3.3 Justification of Exclusion Criteria The exclusion criteria are primarily designed for patient safety. In addition to excluding specific vulnerable populations (e.g., prisoners), these criteria are designed to exclude patients for whom receipt of hydroxychloroquine might increase the risk of serious adverse events. ... | [] |
NCT04332991 | 3.4 | Screening | 3.4 Screening The site investigator or delegate will screen for hospitalized patients with laboratory confirmed COVID-19 (that is, a positive laboratory test for SARS-CoV-2) or a pending SARS-CoV-2 test. Treating clinicians will also be instructed to contact the site investigator or delegate for patients with a high cl... | [] |
NCT04332991 | 3.5 | Assessment of Eligibility and Exclusion Tracking | 3.5 Assessment of Eligibility and Exclusion Tracking For patients who appear to meet inclusion criteria during screening, an electronic case report form will be completed to determine eligibility and track exclusions. The electronic case report form will be accessed and stored in the electronic database. At the time of... | [] |
NCT04332991 | 3.6 | Process of Obtaining Informed Consent | 3.6 Process of Obtaining Informed Consent Informed consent will be obtained from the patient or from a surrogate decision maker if the patient lacks decision-making capacity. In some instances, bringing a paper consent form and pen to the bedside of a patient with known or suspected COVID-19 and then taking these out o... | [] |
NCT04332991 | 3.6.1 | Paper-based approach | 3.6.1 Paper-based approach - 1. The informed consent document is delivered to the patient or LAR. - a. If the patient or LAR is on-site, the informed consent document many be delivered to the patient or LAR either by research staff or by clinical staff - b. If the LAR is off-site, the informed consent document may be e... | [] |
NCT04332991 | 3.6.2 | Electronic/e-consent approach | 3.6.2 Electronic/e-consent approach - 1. The electronic informed consent document is opened on a research device or a link for the electronic informed consent document is sent to the patient's or LAR's device. - 2. Research staff discuss the informed consent document with the patient or LAR either in person or by telep... | [] |
NCT04332991 | 3.6.3 | Attestation of informed consent | 3.6.3 Attestation of informed consent If none of the options outlined above (traditional signature and storage of a paper consent form, electronic photographs of a signed consent page, or e-consent) are available, study personnel may attest to completion of the informed consent process using the procedures outlined bel... | [] |
NCT04332991 | 3.7 | Randomization and Blinding | 3.7 Randomization and Blinding Participants confirmed to meet all eligibility criteria who have provided informed consent will be randomized 1:1 to hydroxychloroquine versus placebo. A randomization code will be provided to the site investigator or delegate from a centralized, web-based platform. Randomization will req... | [] |
NCT04332991 | 3.8 | Minorities and Women | 3.8 Minorities and Women No patients will be excluded on the basis of race, ethnicity, or sex. The clinical coordinating center will monitor recruitment of minorities and women. If necessary, additional recruitment efforts will be made to ensure that the aggregate patient sample contains representative race/ethnicity a... | [] |
NCT04332991 | 4 | STUDY INTERVENTIONS | 4. STUDY INTERVENTIONS | [] |
NCT04332991 | 4.1 | Treatment of Study Participants | 4.1 Treatment of Study Participants A summary of the trial's schedule of events is included in Appendix A. Timing of study procedures is based on the time of randomization, which is defined as "Time 0". The primary outcome will be assessed on Study Day 15, which corresponds to 14 days (2 weeks) after randomization. Stu... | [] |
NCT04332991 | 4.2 | Hydroxychloroquine Group | 4.2 Hydroxychloroquine Group Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg enterally twice daily for the first two doses and then 200 mg twice daily for the subsequent eight doses ("Days 2 – 5"). This dosing regimen is a total of 10 doses over 5 days with an 800 mg l... | [] |
NCT04332991 | 4.3 | Control Group | 4.3 Control Group Participants randomized to the control group will receive matching placebo enterally twice daily matching the dosing regimen described above for hydroxychloroquine. Medication dose packs containing all 10 doses will be provided at randomization by the Investigational Pharmacy. The placebo pills will b... | [] |
NCT04332991 | 4.4 | Co-Interventions | 4.4 Co-Interventions This trial will control the use of hydroxychloroquine vs placebo during the 5-day intervention period. Enrolled participants will not receive open-label hydroxychloroquine or chloroquine during the 5-day intervention period. All other treatment decisions will be made by treating clinicians without ... | [] |
NCT04332991 | 4.5 | On-Study Monitoring | 4.5 On-Study Monitoring All patients enrolled in the study will be initially hospitalized and will therefore receive monitoring as a part of routine clinical care, including monitoring by their physicians, nurses, respiratory therapists, and ancillary staff. In addition to routine clinical monitoring, enrolled patients... | [] |
NCT04332991 | 4.6 | Criteria for Stopping Study Drug | 4.6 Criteria for Stopping Study Drug Administration of the blinded study drug may be stopped temporarily or permanently for (a) adverse events, (b) results of on-study monitoring, (c) clinical deterioration, or (d) evidence of an alternative cause to the patient's symptoms. If a patient experiences an adverse event tha... | [] |
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