protocol_id stringclasses 263
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NCT04562116 | 9.4.1 | Adverse Events | 9.4.1 Adverse Events
Adverse Event Definition An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal lab... | [
"Adverse Event Definition",
"Note(s):",
"Assessment of Severity",
"Assessment of Causality",
"Reasonable Possibility",
"No Reasonable Possibility",
"Action Taken",
"Follow-up of Adverse Events",
"Documentation and Reporting of Adverse Events",
"Adverse Events of Special Interest",
"Serious Adver... |
NCT04562116 | 9.49.4 | Respiratory Referrals | 9.49.4 Respiratory Referrals Subjects with a medical history of asthma will be referred to the physician who manages their asthma when: - PEF < 80% of the predicted value. - ACT score < 19 because an ACT score < 19 conveys asthma that may not be adequately controlled. . Unexpected worsening of asthma is observed or rep... | [] |
NCT04562116 | 9.4.10 | Electrocardiogram | 9.4.10 Electrocardiogram A 12-lead ECG will be performed and read at the site according to visits and time points specified in Table 1. ECGs will be performed in the supine position and before any scheduled vital sign measurements and blood draws. Subjects should be monitored for potentially clinically significant ECG ... | [] |
NCT04562116 | 10 | STATISTICAL METHODS | 10 STATISTICAL METHODS A statistical analysis plan (SAP) will be developed as a separate document. The SAP will contain detailed and technical descriptions of specific data conventions, calculations, and statistical procedures for executing the analyses that are specified in the sections of the clinical study protocol ... | [] |
NCT04562116 | 10.1 | Analysis Populations | 10.1 Analysis Populations The safety population will include all subjects who receive at least 1 dose of nemolizumab. All safety and efficacy data will be summarized using the safety population. The per-protocol population will consist of all subjects who complete the study without any major protocol deviations or any ... | [] |
NCT04562116 | 10.2 | Demographic and Other Baseline Characteristics | 10.2 Demographic and Other Baseline Characteristics Subject disposition, demographics, baseline characteristics, previous therapies and concomitant therapies, and medical history will be summarized descriptively on the safety population and per-protocol populations. | [] |
NCT04562116 | 10.3 | Pharmacokinetic Analysis | 10.3 Pharmacokinetic Analysis The plasma concentrations and PK parameters for the 5 selected CYP substrates and serum nemolizumab concentrations will be summarized descriptively on the per-protocol and safety populations and fully described in the SAP. The primary endpoints are the PK parameters (AUCo-inf, AUCo-1ast, a... | [] |
NCT04562116 | 10.4 | Efficacy Variables | 10.4 Efficacy Variables For each visit, the maximum itch intensity (PP NRS) will be calculated based on the average of daily PP NRS during 7 days immediately preceding that visit. A minimum of 4 daily scores out of the 7 days immediately preceding that visit are required for this calculation. The PP NRS and their perce... | [] |
NCT04562116 | 10.5 | Safety Variables | 10.5 Safety Variables All safety analyses will be based on the safety population. Further details of safety analyses, including extent of exposure, will be provided in the SAP. | [] |
NCT04562116 | 10.5.1 | Treatment-Emergent Adverse Events | 10.5.1 Treatment-Emergent Adverse Events A TEAE is defined as an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. TEAEs will be tabulated in frequency tables by system organ class and preferred term based on the Medical Dictionary for Regulatory Activities (M... | [] |
NCT04562116 | 10.5.2 | Clinical Laboratory | 10.5.2 Clinical Laboratory Laboratory data (absolute values and change from baseline) will be summarized by visit. Shift tables for each visit will be summarized for each laboratory parameter. Reference ranges will be provided in the laboratory manual. | [] |
NCT04562116 | 10.5.3 | Vital Signs | 10.5.3 Vital Signs All vital signs and weight data (absolute values and change from baseline) will be summarized descriptively by visit. In addition, shift from baseline will be summarized by visit. | [] |
NCT04562116 | 10.5.4 | Other Safety Data | 10.5.4 Other Safety Data Other safety data including PEF, ACT, ECG, pregnancy test, ADA will be listed. Summary tables may be provided where appropriate. | [] |
NCT04562116 | 10.6 | Interim Analyses | 10.6 Interim Analyses Not applicable. | [] |
NCT04562116 | 10.7 | Handling of Missing Data | 10.7 Handling of Missing Data No missing imputation will be used in this study. | [] |
NCT04562116 | 10.8 | Determination of Sample Size | 10.8 Determination of Sample Size Approximately 25 subjects will be enrolled to have 15 completed subjects in the per-protocol population to provide a reliable estimate of the magnitude and variability of the interaction. | [] |
NCT04562116 | 10.9 | Protocol Deviations | 10.9 Protocol Deviations All protocol deviations will be identified, evaluated, and closed before the database lock and will be described in the Protocol Deviation Management Plan and clinical study report. | [] |
NCT04562116 | 11 | QUALITY ASSURANCE AND QUALITY CONTROL | 11 QUALITY ASSURANCE AND QUALITY CONTROL | [] |
NCT04562116 | 11.1 | Audit and Inspection | 11.1 Audit and Inspection Study centers and study documentation may be subject to Quality Assurance audit during the course of the study by the sponsor or its nominated representative. In addition, inspections may be conducted by regulatory authorities at their discretion. | [] |
NCT04562116 | 11.2 | Monitoring | 11.2 Monitoring Data for each subject will be recorded on eCRFs. Data collection must be completed for each subject who signs an ICF and is administered study drug. In accordance with current GCP and ICH guidelines, the study monitor will carry out source document verification at regular intervals to ensure that the da... | [] |
NCT04562116 | 11.3 | Personnel Training | 11.3 Personnel Training Study monitors and all relevant personnel will be trained before study initiation on the condition to be treated, the standard operating procedures to be used in this clinical study, the protocol, and all study-specific procedures. Team organization, communication, and operational issues will al... | [] |
NCT04562116 | 11.4 | Data Management | 11.4 Data Management The designated CRO will be responsible for activities associated with the data management of this study. This will include, but is not limited to, setting up a relevant database and data transfer mechanisms, along with appropriate validation of data and resolution of queries. All data management ac... | [] |
NCT04562116 | 11.5 | Clinical Study Conduct | 11.5 Clinical Study Conduct With the exception of avoiding an immediate risk to a subject, the investigator should not deviate from the clinical study protocol or implement any changes without written approval from the sponsor and prior review and documented approval/favorable opinion from the IRB/IEC of a protocol ame... | [] |
NCT04562116 | 11.6 | Amendments | 11.6 Amendments The sponsor may modify the clinical study protocol at any time for ethical, medical, or scientific reasons. Any amendments will be handled according to applicable local regulations. The sponsor does not have to notify non-substantial amendments to the competent authorities or IRB/IEC. However, non-subst... | [] |
NCT04562116 | 11.7 | Quality Management and Risk Evaluation | 11.7 Quality Management and Risk Evaluation Details will be provided in a separate Integrated Quality Risk Management Plan. | [] |
NCT04562116 | 12 | ETHICS | 12 ETHICS | [] |
NCT04562116 | 12.1 | Independent Ethics Committee or Institutional Review Board | 12.1 Independent Ethics Committee or Institutional Review Board Before initiation of the study at each study center, the protocol, the ICF, other written material given to the subjects, and any other relevant study documentation will be submitted to the appropriate IEC/IRB. Written approval of the study and all relevan... | [] |
NCT04562116 | 12.2 | Regulatory Authorities | 12.2 Regulatory Authorities Relevant study documentation will be submitted to the regulatory authorities of the participating countries, according to local/national requirements, for review and approval before the beginning of the study. On completion of the study, the regulatory authorities will be notified that the s... | [] |
NCT04562116 | 12.3 | Ethical Conduct of the Study | 12.3 Ethical Conduct of the Study The investigator(s) and all parties involved in this study should conduct the study in adherence to the ethical principles based on the Declaration of Helsinki, GCP, ICH guidelines, and the applicable national and local laws and regulatory requirements. | [] |
NCT04562116 | 12.4 | Informed Consent | 12.4 Informed Consent The process of obtaining informed consent must be in accordance with applicable regulatory requirement(s) and must adhere to GCP guidelines. The investigator is responsible for ensuring that no subject undergoes any study-related examination or activity before that subject has given written inform... | [] |
NCT04562116 | 12.5 | Subject Confidentiality | 12.5 Subject Confidentiality Monitors, auditors, and other authorized agents of the sponsor and/or its designee, the IEC(s)/IRB(s) approving this research, and the US Food and Drug Administration, as well as that of any other applicable agency(ies), will be granted direct access to the study subjects' original medical ... | [] |
NCT04562116 | 12.6 | Financing and Insurance | 12.6 Financing and Insurance Financing and insurance of this study will be outlined in a separate agreement between the designated CRO and the sponsor. | [] |
NCT04562116 | 13 | REPORTING AND PUBLICATION, INCLUDING ARCHIVING | 13 REPORTING AND PUBLICATION, INCLUDING ARCHIVING Essential documents are those documents that individually and collectively permit evaluation of the study and quality of the data produced. After completion of the study (end of study defined as the date of the last visit of the last subject), all documents and data rel... | [] |
NCT04562116 | 14 | REFERENCES | 14 REFERENCES CCI US Food and Drug Administration. Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers. https://www.fda.gov/drugs/drug-interactionslabeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers - European Medicines Agency. Guideline on the inves... | [] |
NCT04562116 | 15 | APPENDICES | 15 APPENDICES
Appendix 1: American Academy of Dermatology Consensus Criteria for AD Diagnosis Features to be considered in diagnosis of patients with atopic dermatitis:
ESSENTIAL FEATURES; must be present: x Pruritus CCI - x Eczema (acute, subacute, chronic): - o Typical morphology and age-specific patterns\ - o Chro... | [
"Appendix 1: American Academy of Dermatology Consensus Criteria for AD Diagnosis",
"ESSENTIAL FEATURES; must be present:",
"\\Patterns include:",
"IMPORTANT FEATURES; seen in most cases, adding support to the diagnosis:",
"Appendix 6: Specific Guidance for Study Conduct and Subject Safety during the COVID-1... |
NCT04567342 | 1 | Objective | 1. Objective Our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts, MyChart messaging) to children age 12-14 months, 4 years old, or 6-17 years old who are due for a WCC visit and don't have one scheduled in the n... | [
"Background"
] |
NCT04567342 | 2 | Design/Method | 2. Design/Method To achieve our objective, we will conduct a 2 × 2 factorial randomized controlled trial. Randomization is justified because 1) it is a rigorous approach to answer our question and 2) we do not have the resources or appointment availability to personally contact every patient who is eligible and have th... | [
"Patient Population:",
"Factors under study (levels):",
"Personal Contacts (12-14 month & 4-year-olds) Trial:",
"MyChart Trial:",
"Televox (age 6-11yo) Trial:",
"Televox (age 12-17yo) Trial:",
"Response variables (outcomes):",
"Personal Contacts (12-14 months & 4-year-olds) Trial:",
"MyChart and Tel... |
NCT04591626 | 1 | Synopsis | 1. Synopsis
Title of Study: A Randomized, Double-Blind Trial Comparing the Effect of the Addition of Dulaglutide 1.5 mg versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Patients with Type 2 Diabetes (T2D).
Rationale: Glucagon-like peptide-1 (GLP-1) receptor agonists and insulin ... | [
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"Rationale:",
"Objectives:",
"Summary of Study Design:",
"Treatment Arms and Duration:",
"Number of Planned Patients:",
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"Efficacy Analyses:",
"Safety Analyses:"
] |
NCT04591626 | 2 | S c h e d ul e of A cti viti e s | 2. S c h e d ul e of A cti viti e s T a bl e G B G O . 1. S c h e d ul e of A cti viti e s | | | Scree ni ng/ Le a d I n | | | | | | | | | Tre at me nt Peri o d | | | | | | | | S afet yoll o wU p | |------------------------------------------------------------------------------------|-----|-----------------------------|... | [] |
NCT04591626 | 3 | Introduction | 3. Introduction | [] |
NCT04591626 | 3.1 | Study Rationale | 3.1. Study Rationale Initial pharmacological therapy for T2D is based on stepwise addition of oral antihyperglycemic medications (OAMs) when patients become persistently hyperglycemic despite treatment with lifestyle measures (Inzucchi et al.2012). With further progression of the disease, many patients eventually requi... | [] |
NCT04591626 | 3.2 | Background | 3.2. Background A GLP-1 receptor agonist, dulaglutide is a biosynthetic fusion protein molecule produced using mammalian cell cultures, and consists of 2 identical, disulphide-linked chains, each containing an N-terminal glucagon-like peptide-1 (GLP-1) analogue sequence covalently linked to a modified human immunoglobu... | [] |
NCT04591626 | 3.3 | Benefit/Risk Assessment | 3.3. Benefit/Risk Assessment More information about the known and expected benefits, risks, SAEs and reasonably anticipated AEs of dulaglutide can be found in the Investigator's Brochure (IB). In addition, detailed information about the known and expected benefits and risks of dulaglutide can be found in the Trulicity®... | [] |
NCT04591626 | 4 | Objectives and Endpoints | 4. Objectives and Endpoints Table [GBGO.2](#page-20-1) presents the objectives and endpoints of the study.
Table GBGO.2. Objectives and Endpoints | Objectives | Endpoints | |-------------------------------------------------------------------------------------------------------------------------------------------------... | [
"Table GBGO.2. Objectives and Endpoints"
] |
NCT04591626 | 5 | Study Design | 5. Study Design | [] |
NCT04591626 | 5.1 | Overall Design | 5.1. Overall Design Study GBGO is a multicenter, randomized, double-blind, parallel-arm Phase 3b trial that compares the effect of the addition of dulaglutide 1.5 mg QW with the addition of placebo QW to titrated basal insulin glargine, with metformin and/or acarbose, on glycemic control and safety in adult Chinese pat... | [
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"St u d y Peri o d I ( Scree ni n g a n d Le a d I n)",
"Scree ni n g ( Visit 1)",
"Le a d i n ( Visit 2 t Visit 3)",
"St u d y Peri o d II ( Tre at me nt Peri o d):"
] |
NCT04591626 | R | a n d o miz ati o n ( Visit 3) | R a n d o miz ati o n ( Visit 3) At Visit 3 , at ient s h o uld arri ve t o t he cli nic i n t he fast i n g state, w hic h s h o uld last at l east 8 h o urs, wit h o ut ha vi n g ta ke n a n y d oses o f t heir st u d y dr u g, O A Ms a n d i ns uli n glar gi ne. Pr oce d ures at t his visit will be perf or me d as s... | [
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"Titr ati o n Peri o d ( E n d of Visit 6 t o Visit 1 7 [ Weeks t o 2 8 ])",
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"Safety Follow-Up (801) Visit",
"Early Termination Visit (If Necessary)",
"5.2. Number of Participants",
"5.3. End of Study Definition"... |
NCT04591626 | R | e vi s e d Pr ot o c ol S e cti o n s | R e vi s e d Pr ot o c ol S e cti o n s N ote: D el et i ons ha ve bee n i de nt ifie d b y striket hr o u g hs A d dit i ons ha ve bee n i de ntifie d b y t he use of u n dersc ore T he n u m beri n g s yste m use d f or i ncl usi on a n d e xcl usi o n criteria pr o vi des a u ni q ue n u m ber f or eac h crit erio n... | [
"1. y n o p si s",
"2. S c h e d ul e of A cti viti e s"
] |
NCT04591626 | T | a bl e G B G O. 1. S c h e d ul e of A cti viti e s | T a bl e G B G O. 1. S c h e d ul e of A cti viti e s | | | Scree ni ng/ Le a d I n | | Tre at me nt Peri o d | | | | | | | | | | S afet yoll o wU p | | | | | | |-------------------------------------------------------|-----|-----------------------------|---|-----------------------|-----|-----|-----|-----|-----|-----|--... | [
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"Study Period I (Screening and Lead-In)",
"St u d y Peri o d II ( Tre at me nt Peri o d):",
"R a n d o miz ati o n ( Visit 3)",
"St a biliz ati o n Peri o d ( E n d of Visit 3 t o Visit 6 [ Weeks 0 t o 4])",
"Titr ati o n Peri o d ( E n d of Visit 6 ... |
NCT04601597 | 2.1 | Study Design | 2.1 Study Design This was a researcher-initiated, multicenter, randomized controlled trial conducted in six first-class general hospitals in China's Zhejiang, Fujian, Jiangsu, and Liaoning provinces. Twelve IV nurse specialists were involved in performing the catheterizations. The research protocol was based on assigni... | [] |
NCT04601597 | 2.2 | Participants | 2.2 Participants A fixed-point continuous convenience sampling method was adopted to enroll 330 participants. The participants who met the clinical criteria for this study were informed about the study and written informed consent was obtained from each participant. Consent may also have been obtained from legally auth... | [] |
NCT04601597 | 2.3 | Sampling | 2.3 Sampling A general formula-based sample estimation method using the data on the relationship between MC tip position and catheter-related complications was used to calculate the sample size (Wu et al., 2020). Based on the selected reference, the incidence of complications at the tip of the MC at the thoracic wall o... | [] |
NCT04601597 | 2.4 | Randomization and Grouping | 2.4 Randomization and Grouping There were 428 eligible patients,and 330 consented to participating in this study.A random sequence was generated after participants were recruited, and participants were randomized into three groups using a computerized random number generation technique. Then, a proportional allocation ... | [] |
NCT04601597 | 2.4.1 | Study Groups | 2.4.1 Study Groups - 1. Experimental Group 1 contained patients assigned with the numbers obtained after dividing the computer-generated random numbers by three, with a remainder of one. - 2. Experimental Group 2 contained patients assigned with numbers obtained after dividing computer-generated random numbers by three... | [] |
NCT04601597 | 2.5 | Intervention | 2.5 Intervention Detailed history-taking, including medical history, and clinical exams were provided to all participants were,and written informed consent was obtained. A single-blind design wasadopted, in which the participants did not know their inclusion status, or whether they were in the controlor experimental gr... | [] |
NCT04601597 | 2.5.1 | Catheter Pre-Placement Length Measurement and Evaluation of Tip Position | 2.5.1 Catheter Pre-Placement Length Measurement and Evaluation of Tip Position The measurement of catheter pre-placement length and the determination method of catheter tip position were formulated based on the Consensus (Bai & Guo, 2019), expert opinions on vascular anatomy, and relevant literature (Huang et al., 2018... | [] |
NCT04601597 | 2.5.2 | Catheter Insertion Procedure | 2.5.2 Catheter Insertion Procedure A fixed routine for pre-insertion cleaning and equipment was followed, including hand washing, placing the patient in the supine position, skin antisepsis,and preparation of the sterile field. Catheter insertion was performed by senior nurses in the intravenous treatment room, which w... | [] |
NCT04601597 | 2.5.3 | Catheter Maintenance | 2.5.3 Catheter Maintenance As suggested by the relevant literature, members of the research group designed the first draft of the MC tip positioning complication observation table. The observation table was later improved after modification by the IV specialist nurse of each hospital, and a third-party Statistics agent... | [] |
NCT04601597 | 2.6 | Evaluation Indicators and Judgment Criteria | 2.6 Evaluation Indicators and Judgment Criteria | [] |
NCT04601597 | 2.6.1 | Incidence of Catheter-Related Complications | 2.6.1 Incidence of Catheter-Related Complications First, the catheter-related complications were assessed. The complications studied included phlebitis, catheter-related thrombosis, catheter occlusion, catheter dislodgement, bleeding, catheter-related infections, and infiltration.In this assessment, the incidence of ea... | [] |
NCT04601597 | 2.6.2 | Indwelling Catheter Duration | 2.6.2 Indwelling Catheter Duration Indwelling catheter duration referred to the number of days between the date of catheter placement and removal. | [] |
NCT04601597 | 2.7 | Data Collection | 2.7 Data Collection Catheterization nurses recorded baseline data prior to catheterization, and only the most recent results were recorded one week prior to catheterization, when multiple laboratory results were available. Catheterization site evaluations were recorded after placement, and patients were followed up for... | [] |
NCT04601597 | 2.8 | Quality Control | 2.8 Quality Control Quality standards and controls were maintained throughout the study. All hospitals included in thisstudy used the same brand and batch number of silicone-valved catheters, with a total length of 30 cm. Catheters could be trimmed to ensure a consistent length of the external catheter and a unified ca... | [] |
NCT04603495 | 1 | PROTOCOL SUMMARY | 1. PROTOCOL SUMMARY | [] |
NCT04603495 | 1.1 | Synopsis | 1.1. Synopsis Name of Sponsor/Company: Constellation Pharmaceuticals Name of Investigational Product: Pelabresib (CPI-0610) Protocol Number: CPI 0610-04 Title of Study: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive ... | [
"Objectives and Endpoints:",
"Investigational product, dosage, and mode of administration:",
"Statistical Considerations:",
"Analysis populations:",
"Efficacy analysis:",
"Safety analysis:",
"Sample size determination:",
"Data and Safety Monitoring Board (DSMB):"
] |
NCT04603495 | 1.2 | Schema | 1.2. Schema  | [] |
NCT04603495 | 1.3 | Schedule of Activities (SoA) | 1.3. Schedule of Activities (SoA) | Procedure | Section | ScreeningPeriod | | | | Treatment Period (including crossover) | | | | Follow-Up Periodb | | |-------------------------------------|----------|------------------------------------------|----|------------------------------------------------|-------------|--------... | [] |
NCT04603495 | 2 | INTRODUCTION | 2. INTRODUCTION | [] |
NCT04603495 | 2.1 | Background | 2.1. Background MF is a clonal myeloproliferative disease. It shares many of the characteristics of the other myeloproliferative diseases (essential thrombocythemia and polycythemia vera) but is characterized by more exaggerated abnormalities in megakaryocytes and by a more aggressive disease course with complications ... | [] |
NCT04603495 | 2.2 | Study Rationale | 2.2. Study Rationale Preclinical studies suggest that a combination of a BETi and JAKi can result in synergistic reduction of splenomegaly, bone marrow fibrosis, and mutant cell burden [\(Kleppe et al., 2018\)](#page-99-3). These findings support the potential complementary activity of pelabresib and a JAKi for MF trea... | [] |
NCT04603495 | 2.3 | Benefit/Risk Assessment | 2.3. Benefit/Risk Assessment More detailed information about the known and expected benefits and risks and reasonably expected AEs of pelabresib may be found in the pelabresib Investigator's Brochure. | [] |
NCT04603495 | 2.3.1 | Risk Assessment | 2.3.1. Risk Assessment The following events are potential anticipated AEs with pelabresib: - Thrombocytopenia: Thrombocytopenia has been the most consistent and predictable toxicity of pelabresib in patients enrolled in the Phase 1 and Phase 2 studies of pelabresib. In the three Phase I dose escalation clinical studies... | [] |
NCT04603495 | 2.3.2 | Benefit Assessment | 2.3.2. Benefit Assessment There are several mechanisms by which pelabresib has the potential to improve constitutional symptoms and spleen enlargement, and may elicit an effect on the underlying disease through its inhibitory effects on: i) megakaryocyte differentiation and proliferation; ii) inflammatory cytokine expr... | [] |
NCT04603495 | 2.3.3 | Overall Benefit-Risk Conclusion | 2.3.3. Overall Benefit-Risk Conclusion The improvements in spleen volume, constitutional symptoms, hemoglobin levels, and bone marrow fibrosis in patients with MF, when combined with the generally acceptable and manageable safety profile of pelabresib and risk minimization measures, support its continued evaluation in ... | [] |
NCT04603495 | 3 | OBJECTIVES AND ENDPOINTS | 3. OBJECTIVES AND ENDPOINTS The following are the objectives and endpoints to be evaluated in this study. Further description of endpoints, including definitions used and applicable assessments, may be found in Section [9.3.](#page-73-0) | Objectives | Endpoints | |------------------------------------------------------... | [] |
NCT04603495 | 4 | STUDY DESIGN | 4. STUDY DESIGN | [] |
NCT04603495 | 4.1 | Overall Design | 4.1. Overall Design This is a Phase 3, global, multicenter, randomized, double-blind, active-controlled study of pelabresib + ruxolitinib vs placebo + ruxolitinib in JAKi-treatment naïve patients with PMF, PPV-MF, or PET-MF. The study design schematic is shown in Section [1.2.](#page-15-0) adverse event; T1/2 = half-li... | [] |
NCT04603495 | 4.2 | Scientific Rationale for Study Design | 4.2. Scientific Rationale for Study Design Since its global approvals, ruxolitinib is currently the standard of care for patients with MF [\(NCCN, 2019\)](#page-100-7). Ruxolitinib has been proven to primarily reduce spleen volume and to provide symptomatic relief in patients (≥35% reduction from baseline spleen size [... | [] |
NCT04603495 | 4.3 | Justification for Dose | 4.3. Justification for Dose After a review of the safety data on pelabresib across three Phase 1 studies in hematologic malignancies, 225 mg QD was considered to be the recommended Phase 2 dose of pelabresib as monotherapy. However, a lower starting dose of pelabresib (125 mg QD) was chosen for the Phase 2 MANIFEST stu... | [] |
NCT04603495 | 4.4 | DSMB | 4.4. DSMB An independent DSMB will be used to review data to monitor patient safety in the study. The DSMB will review safety data at regular intervals. The DSMB will also be provided with enrollment updates. The DSMB may provide recommendations based on their review of the data, including whether to halt the study due... | [] |
NCT04603495 | 4.5 | Study Participation | 4.5. Study Participation | [] |
NCT04603495 | 4.5.1 | Screen Failures | 4.5.1. Screen Failures Screen failures are defined as patients who consent to participate in the clinical study but are not subsequently enrolled in the study or randomly assigned to study drug. A minimal set of screen failure information is required to ensure transparent reporting of screen failure patients to meet th... | [] |
NCT04603495 | 4.5.2 | Duration of Treatment and Study Participation | 4.5.2. Duration of Treatment and Study Participation Patients may receive treatment in the study until disease progression or discontinuation or withdrawal from treatment (Section [7.1\)](#page-57-2), whichever occurs first, and will subsequently be followed for disease progression and overall survival. | [] |
NCT04603495 | 4.5.3 | Patient Follow-Up | 4.5.3. Patient Follow-Up Patients who discontinue treatment in the absence of disease progression will enter the progression-free survival (PFS) follow-up period until disease progression (central radiology assessment confirmation is required for splenic progression) or until initiation of another systemic anti-cancer ... | [] |
NCT04603495 | 4.5.4 | End of Study | 4.5.4. End of Study The sponsor may end the study when the availability of an early access program or roll-over protocol exists into which patients remaining on study may enter and continue to receive access to drug if they are deriving clinical benefit and/or being monitored for long-term follow-up. Such a protocol wo... | [] |
NCT04603495 | 5 | STUDY POPULATION | 5. STUDY POPULATION Prospective approval of protocol deviations to eligibility criteria, also known as protocol waivers or exemptions, is not permitted. | [] |
NCT04603495 | 5.1 | Inclusion Criteria | 5.1. Inclusion Criteria Patients are eligible to be included in the study only if all of the following criteria apply:
Age 1. ≥ 18 years of age at the time of signing the informed consent
Type of Patient and Disease Characteristics - 2. Have a confirmed diagnosis of MF (PMF or PPV-MF or PET-MF) in accordance with the... | [
"Age",
"Type of Patient and Disease Characteristics",
"Informed Consent"
] |
NCT04603495 | 5.2 | Exclusion Criteria | 5.2. Exclusion Criteria Patients are excluded from the study if any of the following criteria apply:
Medical Conditions - 1. Had splenic irradiation within 6 months of starting study drug. - 2. Had prior splenectomy. - 3. Are a candidate for, and willing to undergo allogeneic HSCT, and, in the opinion of the Investiga... | [
"Medical Conditions",
"Prior/Concomitant Therapy",
"Other Exclusions"
] |
NCT04603495 | 6 | STUDY DRUG | 6. STUDY DRUG Study drug is defined as any investigational intervention, marketed product, or placebo intended to be administered to a study patient for evaluation of safety and efficacy according to the study protocol. Study treatment is defined as the combination of pelabresib + ruxolitinib or placebo + ruxolitinib. ... | [] |
NCT04603495 | 6.1 | Study Drugs Administered | 6.1. Study Drugs Administered The study drugs outlined in [Table](#page-36-1) 1 will be administered. Table 1: Study Drugs to be Administered | Arm Name | Experimental Group(pelabresib + ruxolitinib) | Control Group(placebo + ruxolitinib) | |----------------------------------------------|-------------------------------... | [] |
NCT04603495 | 6.2 | Preparation/Handling/Storage/Accountability | 6.2. Preparation/Handling/Storage/Accountability The Investigator or designee must confirm appropriate temperature conditions have been maintained during transit for all study drug received and any discrepancies are reported and resolved before use of the study drug. Only patients enrolled in the study may receive stud... | [] |
NCT04603495 | 6.3 | Measures to Minimize Bias: Randomization and Blinding | 6.3. Measures to Minimize Bias: Randomization and Blinding This study has a double-blind design in which patients and investigators are blinded to study drug; study drugs will be packaged identically (Section [6.1\)](#page-36-0). All patients will be randomly assigned to either treatment group in a 1:1 ratio using a ce... | [] |
NCT04603495 | 6.4 | Study Drug Compliance | 6.4. Study Drug Compliance When patients are dosed at the site, they will receive study drug directly from the Investigator or designee, under medical supervision. The date and time of each dose administered in the clinic will be recorded in the source documents and recorded in the eCRF. The dose of study drug and stud... | [] |
NCT04603495 | 6.5.1 | Starting Doses of Pelabresib/Placebo and Ruxolitinib | 6.5.1. Starting Doses of Pelabresib/Placebo and Ruxolitinib The starting doses for ruxolitinib and pelabresib/placebo at Cycle 1 Day 1 and the subsequent ruxolitinib dose increase at Cycle 2 Day 1 are detailed in [Table](#page-40-1) 2. - o The MANDATORY starting dose for the treatment regimen at Cycle 1 Day 1 will be p... | [] |
NCT04603495 | 6.5.2 | Criteria and Process to Increase Doses of Ruxolitinib and Pelabresib/Placebo | 6.5.2. Criteria and Process to Increase Doses of Ruxolitinib and Pelabresib/Placebo | [] |
NCT04603495 | 6.5.2.1 | Ruxolitinib Dose Increases for Lack of Spleen Response | 6.5.2.1. Ruxolitinib Dose Increases for Lack of Spleen Response Following the mandatory dose increase on Cycle 2 Day 1 described above in Section [6.5.1](#page-39-2) and [Table](#page-40-1) 2, the ruxolitinib dose may be increased by 5 mg BID increments from Cycle 3 Day 1 or thereafter if all the criteria outlined belo... | [] |
NCT04603495 | 6.5.2.2 | Pelabresib/Placebo Dose Uptitration Rules for Lack of Spleen Response | 6.5.2.2. Pelabresib/Placebo Dose Uptitration Rules for Lack of Spleen Response Pelabresib/placebo dose increase is only allowed from Cycle 5 Day 1 or thereafter based on the criteria outlined below. Patients who have not had a dose reduction or hold because of an AE in previous cycles may increase the pelabresib/placeb... | [] |
NCT04603495 | 6.5.3 | Ruxolitinib and Pelabresib/Placebo Dose Modification and Restarting Rules for Platelet Count Decrease and Other Toxicities | 6.5.3. Ruxolitinib and Pelabresib/Placebo Dose Modification and Restarting Rules for Platelet Count Decrease and Other Toxicities Guidance for dose modification of ruxolitinib is outlined below. If a patient experiences a TEAE (e.g., platelet count decrease or other toxicities as specified in [Table 3](#page-42-0) and ... | [] |
NCT04603495 | 6.5.4 | Re-escalation Criteria and Process | 6.5.4. Re-escalation Criteria and Process | [] |
NCT04603495 | 6.5.4.1 | Re-escalation of Ruxolitinib after Dose Reduction for Toxicity | 6.5.4.1. Re-escalation of Ruxolitinib after Dose Reduction for Toxicity If a dose of ruxolitinib has been reduced for a given patient, the dose may be increased on Day 1 of the next cycle. Doses may be increased in 5 mg BID increments and should not be increased more frequently than once every cycle (3 weeks). When con... | [] |
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