protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT04642950 | 15.2 | Withdrawal of a subject from the study | 15.2 Withdrawal of a subject from the study A subject who meets any of the following criteria shall be withdrawn from study participation. - (1) The subject was found not to meet the inclusion criteria or to meet the exclusion criteria and to be ineligible for the clinical study according to the results of medical exam... | [
"[Rationale]"
] |
NCT04642950 | 15.3 | Premature termination of entire or a part of the study | 15.3 Premature termination of entire or a part of the study - (1) If the sponsor decides to discontinue a part of or entire clinical study, the sponsor should promptly report the details of the discontinuation and the reasons to all the principal investigators, the heads of all the medical institution, and the regulato... | [] |
NCT04642950 | 16 | Protocol Compliance and Amendment | 16 Protocol Compliance and Amendment | [] |
NCT04642950 | 16.1 | Protocol compliance and deviation | 16.1 Protocol compliance and deviation - (1) This study shall be conducted in compliance with the protocol in agreement between the principal investigator and the sponsor. - (2) The investigators shall not deviate from or change the protocol without prior written agreement with the sponsor and prior approval by the IRB... | [] |
NCT04642950 | 16.2 | Protocol amendment | 16.2 Protocol amendment - (1) The sponsor must revise the protocol in consultation with the medical experts when applicable to the following items. - The sponsor has known information related to the quality, efficacy, and safety of the test drug or other information important for proper conduct of the clinical study. -... | [] |
NCT04642950 | 17 | Statistical Analysis | 17 Statistical Analysis Statistical analysis will be performed in accordance with "Statistical Principles for Clinical Studies"(Notification No. 1047 of the Evaluation and Licensing Division, PMSB dated November 30, 1998). The analysis items and technical details described in this section should be described separately... | [] |
NCT04642950 | 17.1 | Analysis sets | 17.1 Analysis sets | [] |
NCT04642950 | 17.1.1 | Efficacy analysis set | 17.1.1 Efficacy analysis set The Full Analysis Set (FAS) is defined as any of the assigned subjects, excluding those who were not administered with the study drug or for whom no information on efficacyafter allocation was available. Analysis in FAS will be performed in this study. | [] |
NCT04642950 | 17.1.2 | Safety population | 17.1.2 Safety population All subjects who received the assigned study drug will be included in the Safety Population (SP). | [] |
NCT04642950 | 17.2 | Statistical analysis items and analytical method | 17.2 Statistical analysis items and analytical method Details of the analysis items and analytical methods will be provided in the statistical analysis plan. | [] |
NCT04642950 | 17.2.1 | Subject characteristics | 17.2.1 Subject characteristics Regarding the background parameters of the subjects, the frequency distribution (number of subjects, %) for categorical data, summary statistics (mean, standard deviation, median, minimum, maximum, etc.) for continuous data, and the frequency distribution as necessary when data are catego... | [] |
NCT04642950 | 17.2.2 | Efficacy evaluation | 17.2.2 Efficacy evaluation Regarding the number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28, an efficacy endpoint, the improvement rate by treatment group will be estimated using Kaplan-Meier method, and an analysis for comparison between groups at a significance... | [] |
NCT04642950 | 17.2.3 | Safety evaluation | 17.2.3 Safety evaluation
(1) AEs and ADRs Regarding all AEs and ADRs that occurred, the number of subjects and the number of events will be tabulated by event and by severity of the event by treatment group. In addition, a 95% confidence interval will be calculated for the incidence of AEs by treatment group. Moreover... | [
"(1) AEs and ADRs",
"(2) Laboratory test and vital signs"
] |
NCT04642950 | 17.3 | Exploratory analysis | 17.3 Exploratory analysis Additionally, exploratory analysis will be conducted as needed. Moreover, graphs and/or tables will be prepared as necessary. | [] |
NCT04642950 | 17.4 | Handling procedures for missing, non-adopted and abnormal data | 17.4 Handling procedures for missing, non-adopted and abnormal data - (1) If measurement error, other artificial error, etc. are scientifically proven in the laboratory measurement, re-measurement results will be adopted. - (2) if the reason of occurrence of abnormal data is not clear, such data will be used for evalua... | [] |
NCT04642950 | 17.5 | Significance Level | 17.5 Significance Level As a rule, the significance level will be set at two-sided 5% and the confidence coefficient (1-α) for interval estimation will be set at two-sided 95%. | [] |
NCT04642950 | 17.6 | Changes of analysis plan | 17.6 Changes of analysis plan - (1) When the analysis plan is to be changed, the person in charge for statistical analysis and the statistical analysis manager will prepare a revised statistical analysis plan after clarifying the timing of the change, its purpose, and the effect of the change on the interpretation of t... | [] |
NCT04642950 | 18 | Target Number of Subjects | 18 Target Number of Subjects 60 subjects (randomized in a 2:1 ratio to either of the active treatment group or the control group)
[Rationale] In a preliminary analysis of the ACTT study18 of remdesivir among other preceding studies in COVID-19 patients, no data on the number of days to achieve at least 2-rank improvem... | [
"[Rationale]"
] |
NCT04642950 | 19 | Study Period | 19 Study Period October 2020 to October 2021 | [] |
NCT04642950 | 20 | eCRF and Others | 20 eCRF and Others | [] |
NCT04642950 | 20.1 | Data entry in eCRF and reporting | 20.1 Data entry in eCRF and reporting An eCRF will be applied for the case report form. Based on the source documents, data entry will be performed by the investigators or study collaborator using the Electronic Data Capture (EDC) system designated by the sponsor, thus the eCRF will be prepared. Data entry by the study... | [] |
NCT04642950 | 20.2 | Confirmation of eCRF by the principal investigator | 20.2 Confirmation of eCRF by the principal investigator The details entered by the subinvestigator or study collaborator will be checked by the principal investigator at each time or before data fixation. The principal investigator will check the details entered in the EDC system, confirm that all the entered data (inc... | [] |
NCT04642950 | 20.3 | Data lock and unlock of eCRF | 20.3 Data lock and unlock of eCRF After data cleaning of the eCRF has been completed by the sponsor and the CRO, then all the entered data in the eCRF will be confirmed and electronically signed by the principal investigator. After above mentioned procedures have been completed, the person in charge of data management ... | [] |
NCT04642950 | 21 | Source Documents | 21 Source Documents The source documents are the records including medical records, laboratory test records, and treatment records of the study drug, and others necessary for the reproducibility and evaluation of the factual process of the clinical study. Also, the source documents include the documents, data, and reco... | [] |
NCT04642950 | 21.1 | Direct access to source data and documents | 21.1 Direct access to source data and documents The principal investigator and the medical institution will give direct access upon request from the sponsor and CRO monitors, auditors, IRB, and regulatory authorities so that they can investigate and confirm the documents including the source documents and the study rel... | [] |
NCT04642950 | 21.2 | Data to be handled as source document in the eCRF | 21.2 Data to be handled as source document in the eCRF If the following data are not written in the source document, the information directly entered in the eCRF will be regarded as the source document. - (1) Confirmation of inclusion and exclusion criteria. - (2) Judgement of the severity and seriousness of AEs, causa... | [] |
NCT04642950 | 22 | Quality Control and Quality Assurance | 22 Quality Control and Quality Assurance The sponsor will control and ensure quality of the study based on the standard operating procedures (SOP) to verify whether the quality of the clinical study is ensured. | [] |
NCT04642950 | 22.1 | Quality control | 22.1 Quality control The sponsor will confirm that the following major activities are appropriately performed according to each SOP. - (1) In order to standardize the methods of the clinical study, the sponsor will explain the procedures for selection, enrollment, examination, evaluation, and others of subjects to the ... | [] |
NCT04642950 | 22.2 | Quality assurance | 22.2 Quality assurance The audit manager will inspect whether the clinical study is being conducted in compliance with the protocol, SOPs, the Pharmaceuticals and Medical Devices Act, and related regulations such as GCP in accordance with the sponsor's SOP. Organizations to be audited will be the sponsor, CRO, and the ... | [] |
NCT04642950 | 23 | Ethics | 23 Ethics | [] |
NCT04642950 | 23.1 | Compliance of GCP and others | 23.1 Compliance of GCP and others This clinical study will be conducted in compliance with the ethical principles based on the Declaration of Helsinki (1964) and its revised editions, the standards prescribed in Article 14, Paragraph 3 and Article 80-2 of the Pharmaceuticals and Medical Devices Law, the Ministerial Ord... | [] |
NCT04642950 | 23.2 | Review by IRB | 23.2 Review by IRB Prior to conducting a clinical study, the IRB established by the medical institution will obtain the protocol, informed consent form, investigator's brochure, and other documents requested by the IRB, judge the conduct and continuation of the clinical study from the viewpoint of ethical , scientific,... | [] |
NCT04642950 | 23.3 | Subject confidentiality | 23.3 Subject confidentiality The investigators shall give due consideration to the confidentiality of the subject. Only the subject identification code is to be entered in the eCRF. If confidential information such as the name of the subject is displayed in other documents/materials to be submitted to the sponsor, such... | [] |
NCT04642950 | 23.4 | Compensation for health damages | 23.4 Compensation for health damages The sponsor will be insured and take other measures to ensure the costs required for the treatment of study-related health damage and other loss compensation measures. | [] |
NCT04642950 | 23.5 | Payment policy | 23.5 Payment policy Payments of money related to the clinical study will be described separately in a written agreement or contract agreement between the sponsor and the medical institution. | [] |
NCT04642950 | 24 | Retention of Record | 24 Retention of Record | [] |
NCT04642950 | 24.1 | Retention of records and others | 24.1 Retention of records and others | [] |
NCT04642950 | 24.1.1 | Sponsor | 24.1.1 Sponsor The study related documents that have to be retained will be specified in the GCP and SOP. | [] |
NCT04642950 | 24.1.2 | Medical institution | 24.1.2 Medical institution The study related documents that have to be retained will be specified in the GCP and the SOP of the medical institution. | [] |
NCT04642950 | 24.2 | Retention period | 24.2 Retention period | [] |
NCT04642950 | 24.2.1 | Sponsor | 24.2.1 Sponsor The sponsor will retain the specified study related documents until the day specified as (1) or (2), whichever comes later. - (1) The day 5 years after the date of the manufacturing and marketing approval of the test drug. However, in the case of the drug that must be reexamined according to Article 14-4... | [] |
NCT04642950 | 24.2.2 | Medical institution | 24.2.2 Medical institution The head of the medical institution will retain the prespecified study related documents until the day specified as (1) or (2), whichever comes later. If the sponsor requires a longer time period for retention, the head of the medical institution will discuss how long and how to retain the do... | [] |
NCT04642950 | 24.2.3 | Founder of IRB | 24.2.3 Founder of IRB The founder of the IRB will retain the prespecified study related documents until the day specified as (1) or (2), whichever comes later. If the sponsor requires a longer time period for retention, the founder of the IRB will discuss how long and how to retain the documents with the sponsor. When ... | [] |
NCT04642950 | 25 | Publication Policy | 25 Publication Policy The sponsor has the copyright for publications prepared or delegated on the basis of the results of the sponsored clinical study. The sponsor also possesses ownership of the information contained in this protocol (especially unpublished data). Therefore, even if the information is provided by the ... | [] |
NCT04642950 | 26 | List of Attachments | 26 List of Attachments Attachment 1: Study Administrative Structure, Medical institutions, and Principal investigators | [] |
NCT04642950 | 27 | Reference | 27 Reference - 1 Ministry of Health, Labour and Welfare Headquarters for the Promotion of Measures against New Coronavirus Infectious Diseases. Guide to new coronavirus infections (COVID-19) practice, 3rd edition. Published on September 4, 2020 (or updated thereafter) - 2 Nobel Pharma Co. Ltd. Investigator's Brochure f... | [] |
NCT04732000 | 1 | PURPOSE OF THE STUDY | 1. PURPOSE OF THE STUDY
a. Brief Summary Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. Most approaches designed to limit chronic pain or enhance functional recovery focus on modulating peripheral or CNS responses and not on preventative strategieSs... | [
"a. Brief Summary",
"b. Objectives",
"c. Rationale for Research in Humans"
] |
NCT04732000 | 2 | STUDY PROCEDURES | 2. STUDY PROCEDURES
a. Procedures Participants will be consented prior to the initiation of any study procedures. Participants will be recruited from the Stanford orthopedic population scheduled to undergo total hip replacement surgery. The anesthetic and perioperative management of patients will be standardized accor... | [
"a. Procedures",
"b. Procedure Risks",
"c. Use of Deception in the Study",
"d. Use of Audio and Video Recordings",
"e. Alternative Procedures or Courses of Treatment",
"f. Will it be possible to continue the more (most) appropriate therapy for the participant(s) after the conclusion of the study?",
"g. ... |
NCT04732000 | 3 | BACKGROUND | 3. BACKGROUND
a. Past Experimental and/or Clinical Findings Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. Chronic pain after surgery, for example, affects 10-80% of all those having operations, while commonly performed hip and knee joint replacemen... | [
"a. Past Experimental and/or Clinical Findings",
"References",
"b. Findings from Past Animal Experiments"
] |
NCT04732000 | 4 | RADIOISOTOPES OR RADIATION MACHINES | 4. RADIOISOTOPES OR RADIATION MACHINES
a. Standard of Care (SOC) Procedures | Identify Week/Month of Study | Name of Exam | Identify if SOC or Research | |------------------------------|--------------|-----------------------------| | NA | NA | NA |
b. Radioisotopes i. Radionuclide(s) and chemical form(s) NA ii. Total... | [
"a. Standard of Care (SOC) Procedures",
"b. Radioisotopes",
"c. Radiation Machines – Diagnostic Procedures",
"d. Radiation Machines – Therapeutic Procedures"
] |
NCT04732000 | 5 | DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY | 5. DRUGS, BIOLOGICS, REAGENTS, OR CHEMICALS USED IN THE STUDY
a. Investigational Drugs, Biologics, Reagents, or Chemicals N/A
b. Commercial Drugs, Biologics, Reagents, or Chemicals | Commercial Product 1 | | | |------------------------------|-------------------------------------------------|--| | Name: | N-Acetyl Cys... | [
"a. Investigational Drugs, Biologics, Reagents, or Chemicals",
"b. Commercial Drugs, Biologics, Reagents, or Chemicals"
] |
NCT04732000 | 6 | PARTICIPANT POPULATION | 6. PARTICIPANT POPULATION
a. Planned Enrollment - i) 30 participants enrolled with an expected 20 to complete all study procedures. - ii) 30 - iii) Orthopedic surgery patients undergoing clinically indicated total hip arthroplasty.
b. Age, Gender, and Ethnic Background 18 years of age or older Both men and women All ... | [
"a. Planned Enrollment",
"b. Age, Gender, and Ethnic Background",
"c. Vulnerable Populations",
"d. Rationale for Exclusion of Certain Populations",
"e. Stanford Populations",
"f. Healthy Volunteers",
"g. Recruitment Details",
"h. Eligibility Criteria",
"ii. Exclusion Criteria",
"i. Screening Proce... |
NCT04732000 | 7 | RISKS | 7. RISKS
a. Potential Risks i. Investigational devices NA ii. Investigational drugs NA iii. Commercially available drugs, biologics, reagents or chemicals In the literature the most frequently reported adverse events attributed to I.V. acetylcysteine administration were rash, urticaria, and pruritus. The frequency of ... | [
"a. Potential Risks",
"None known",
"x. Overall evaluation of risk",
"b. International Research Risk Procedures",
"c. Procedures to Minimize Risk",
"d. Study Conclusion",
"e. Data Safety Monitoring Plan (DSMC)",
"f. Risks to Special Populations"
] |
NCT04732000 | 8 | BENEFITS | 8. BENEFITS There is some hope that participants recovery will be positively affected by the infusion of Nacetylcysteine though this is not guaranteed. Acquisition of knowledge regarding oxidative stress, and use of antioxidants in the context of surgery and trauma may impact medical practice and significantly benefit ... | [] |
NCT04732000 | 9 | PRIVACY AND CONFIDENTIALITY | 9. PRIVACY AND CONFIDENTIALITY All participant information and specimens are handled in compliance with the Health Insurance Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford Health Care, and Stanford Children's Health. December 13, 2023 Page 11 of 11 | [] |
NCT04804813 | 1 | 0 B A C K G R O U N D O F I M P L E M E N T A TI O N | 1. 0 B A C K G R O U N D O F I M P L E M E N T A TI O N I n t he Ja pa nese a n d o verseas cli nical st u dies of C A B O M E T Y X Ta blets ( Herei nafter referre d t o as Ca b o met y x i n patie nts wit h re nal cell carci n o ma, he patic f u ncti o n dis or der a p plica ble t o H y's La w N ote was n ot re p ort... | [] |
NCT04804813 | 2 | 0 O BJ E C TI V E S | 2. 0 O BJ E C TI V E S To i n vesti gate t he occ urre nce stat us of a d verse reacti o ns (a d verse e ve nts), es peciall y he patic fail ure, he patic f u ncti o n dis or der, a n d pa ncreatitis (I nf or mati o n o n i nci de nce, se verit y, treat me nt, c o urse, o utc o me, etc.) i n patie nts wit h u nresecta ... | [] |
NCT04804813 | 3 | 0 S A F E T Y S P E CI FI C A TI O N | 3. 0 S A F E T Y S P E CI FI C A TI O N He patic fail ure, he patic f u ncti o n dis or der, pa ncreatitis | [] |
NCT04804813 | 4 | 0 P L A N N E D S A M P L E SI Z E A N D R A TI O N A L E | 4. 0 P L A N N E D S A M P L E SI Z E A N D R A TI O N A L E | [] |
NCT04804813 | 4 | 1 L A N N E D S A M P L E SI Z E | 4. 1 L A N N E D S A M P L E SI Z E Ca b o met y x m o n ot hera p y: 3 0 0 patie nts (as re gistere d patie nts) Patie nts treate d wit h ni v ol u ma b c o m bi nati o n t hera p y: 5 0 patie nts (as t he n u m ber of e nr olle d patie nts) | [] |
NCT04804813 | 4 | 2 A TI O N A L E | 4. 2 A TI O N A L E Ca b o met y x M o n ot hera p y Cases: I n St u d y Ca b oza nti ni b -2 0 0 1, 7/ 3 5 ( 2 0. 0 %) patie nts ha d A L T or A S T ele vati o ns > 3 × U L N. Si nce it was c o nsi dere d p ossi ble t o e val uate t he e ve nt at a certai n le vel b y c ollecti n g at least 5 0 patie nts, t he pla n n... | [] |
NCT04804813 | 5 | 0 S T U D Y P O P U L A TI O N | 5. 0 S T U D Y P O P U L A TI O N To be c o n d ucte d i n patie nts wit h u nresecta ble or metastati c re nal cell carci n o ma. H o we ver, patie nts w h o meet a n y of t he f oll o wi n g e xcl usi o n criteria will n ot be i ncl u de d i n t he st u d y. Refer t o t he pac ka ge i nsert. E xcl usi o n Criteria T ... | [] |
NCT04804813 | 6 | 0 D O S A G E A N D A D MI NI S T R A TI O N | 6. 0 D O S A G E A N D A D MI NI S T R A TI O N T he us ual a d ult d osa ge is 6 0 m g of ca b oza nti ni b a d mi nistere d orall y o nce dail y i n t he faste d state. T he d ose ma y be re d uce d acc or di n g t o t he patie nt's c o n diti o n. W he n a d mi nisteri n g i n c o m bi nati o n wit h ni v ol u ma b ... | [] |
NCT04804813 | 7 | 0 P L A N N E D N U M B E R O F M E DI C A L I N S TI T U TI O N S B Y D E P A R T M E N T | 7. 0 P L A N N E D N U M B E R O F M E DI C A L I N S TI T U TI O N S B Y D E P A R T M E N T De part me nt of Ne p hr ol o g y a n d Ur ol o g y, etc. A p pr o xi matel y 1 5 0 sites | [] |
NCT04804813 | 8 | 0 M E T H O D S | 8. 0 M E T H O D S | [] |
NCT04804813 | 8 | 1 B S E R V A TI O N P E RI O D | 8. 1 B S E R V A TI O N P E RI O D 2 6 wee ks If a d mi nistrati o n of Ca b o met y x is disc o nti n ue d f or a n y reas o n, patie nts will be m o nit ore d u ntil 3 0 da ys after disc o nti n uati o n of a d mi nistrati o n of Ca b o met y x or t he start of s u bse q ue nt s yste mic a ntica ncer t hera p y, w hi... | [
"\\ Rati o nale f or t he o bser vati o n peri o d"
] |
NCT04804813 | 8 | 2 E Q U E S T T O S T U D Y SI T E S A N D C O N T R A C T | 8. 2 E Q U E S T T O S T U D Y SI T E S A N D C O N T R A C T Ta ke da P har mace utical C o m pa n y Li mite d. will c o ncl u de a writte n c o ntract wit h eac h st u d y site pri or t o t he c o n d uct of t his o bser vati o nal st u d y. | [] |
NCT04804813 | 8 | 3 A TI E N T C O N S E N T | 8. 3 A TI E N T C O N S E N T Pri or t o patie nt e nr oll me nt, t he i n vesti gat or will e x plai n t he c o nte nts of t he i nf or me d c o nse nt f or m t o t he patie nt ( or his/ her le gall y acce pta ble re prese ntati ve) a n d o btai n oral or writte n c o nse nt fr o m t he patie nt ( or his/ her le gall ... | [] |
NCT04804813 | 8 | 4 A TI E N T E N R O L L M E N T M E T H O D | 8. 4 A TI E N T E N R O L L M E N T M E T H O D T he st u d y will be c o n d ucte d b y a "ce ntral re gistrati o n met h o d " usi n g a n electr o nic data ca pt ure s yste m ( Herei nafter referre d t o as E D C) via We b. F or patie nts t o w h o m Ca b o met y x is prescri be d after t he first da y of t he c o n... | [] |
NCT04804813 | 8 | 5 R E P A R A TI O N A N D S U B MI S SI O N O F S U R V E Y F O R M S | 8. 5 R E P A R A TI O N A N D S U B MI S SI O N O F S U R V E Y F O R M S I nf or mati o n will be c ollecte d usi n g E D C. T he i n vesti gat or or a pers o n desi g nate d b y t he i n vesti gat or will e nter data i n E D C f or all re gistere d patie nts pr o m ptl y after perf or mi n g necessar y o bser vati o ... | [] |
NCT04804813 | 9 | 0 P L A N N E D S T U D Y P E RI O D | 9. 0 P L A N N E D S T U D Y P E RI O D S t u d yperi o d: Marc h 2 0 2 1 t o Marc h 2 0 2 4 Patie nt re gistrati o n peri o d: Marc h 2 0 2 1 t o 2 0 2 3 A u g ust N ote) N ote) E ve n patie nts f or w h o m Ca b o met y x is prescri be d b y A u g ust 3 1, 2 0 2 3 , patie nt re gistrati o n (e ntr y i n E D C) will n... | [
"1 0. 0 I N V ES TI G A TI O N I T E M S",
"1 0. 1 A TI E N T R E GI S T R A TI O N",
"1 0. 2 A TI E N T C H A R A C T E RI S TI C S",
"2) Ti mi n g of st u d y",
"1 0. 3 E T AI L S O F T R E A T M E N T",
"1) I n vesti gati o n ite ms",
"2) Ti mi n g of st u d y",
"1 0. 4 E S T O B S E R V A TI O N I... |
NCT04804813 | D | oc u me nt Hist or y | D oc u me nt Hist or y | | | | | Comments | | |----------------------------------|-------------------------------------|----------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------... | [] |
NCT04823611 | A | Phase 1 and 2 study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of AZD8233 following a multiple subcutaneous dose administration in Japanese participants with dyslipidemia ( HAYATE ) | A Phase 1 and 2 study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of AZD8233 following a multiple subcutaneous dose administration in Japanese participants with dyslipidemia ( HAYATE ) Sponsor Name: AstraZeneca K.K., 3-1, Ofuka-cho, Kita-ku, Osaka 530-0011, Japan Regulatory Age... | [
"Amendment 1 ( 13-Nov-2020)",
"Overall Rationale for the Amendment:",
"Amendment 2 ( 10-May-2021)",
"Amendment 3 ( 02-Nov-2021)",
"Amendment 4 ( 16-Jun-2022)",
"1 PROTOCOL SUMMARY",
"1.1 Synopsis",
"Protocol Title:",
"Short Title:",
"Rationale:",
"Objectives and Endpoints",
"[Part A/Part C]",
... |
NCT04823611 | A | 1 Regulatory and Ethical Considerations | A 1 Regulatory and Ethical Considerations - This study will be conducted in accordance with the protocol and with the following: - Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) Internationa... | [
"Regulatory Reporting Requirements for SAEs"
] |
NCT04823611 | A | 2 Financial Disclosure | A 2 Financial Disclosure Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial information as requested to allow the sponsor to submit complete and accurate financial certification or disclosure statements to the appropriate regulatory authorities. Investigators are responsibl... | [] |
NCT04823611 | A | 3 Informed Consent Process | A 3 Informed Consent Process - The investigator or his/her representative will explain the nature of the study to the participant or his/her legally authorised representative and answer all questions regarding the study. - Participants must be informed that their participation is voluntary and they are free to refuse t... | [] |
NCT04823611 | A | 4 Data Protection | A 4 Data Protection - Participants will be assigned a unique identifier by the sponsor. Any participant records or datasets that are transferred to the sponsor will contain the identifier only; participant names or any information which would make the participant identifiable will not be transferred. - The participant ... | [] |
NCT04823611 | A | 5 Committees Structure | A 5 Committees Structure The safety of all AstraZeneca clinical studies is closely monitored on an on-going basis by AstraZeneca in consultation with AstraZeneca Patient Safety representatives. Issues identified will be addressed; for instance this could involve amendments to the Clinical Study Protocol and letters to ... | [
"[Part A]"
] |
NCT04823611 | A | 6 Dissemination of Clinical Study Data | A 6 Dissemination of Clinical Study Data A description of this clinical study will be available on http://astrazenecagrouptrials.pharmacm.com and http://www.clinicaltrials.gov as will the summary of the main study results when they are available. The clinical study and/or summary of main study results may also be avail... | [] |
NCT04823611 | A | 7 Data Quality Assurance | A 7 Data Quality Assurance - All participant data relating to the study will be recorded on eCRF unless transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF. - The investig... | [] |
NCT04823611 | A | 8 Source Documents | A 8 Source Documents - Source documents provide evidence for the existence of the participant and substantiate the integrity of the data collected. Source documents are filed at the investigator's site. - Data entered in the eCRF that are transcribed from source documents must be consistent with the source documents or... | [] |
NCT04823611 | A | 9 Study and Site Start and Closure | A 9 Study and Site Start and Closure The study start date is the date on which the clinical study will be open for recruitment of participants. The first act of recruitment is the first site open and will be the study start date. The sponsor designee reserves the right to close the study site or terminate the study at ... | [] |
NCT04823611 | A | 10 Publication Policy | A 10 Publication Policy - The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments. - The sponso... | [
"Appendix B Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting"
] |
NCT04823611 | B | 1 Definition of Adverse Events | B 1 Definition of Adverse Events An adverse event is the development of any untoward medical occurrence in a patient or clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (... | [] |
NCT04823611 | B | 2 Definition of Serious Adverse Events | B 2 Definition of Serious Adverse Events A serious adverse event is an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: - Results in death - Is immediately life-threatening - Requires in-participant hospitalisation or prolongation of ex... | [
"Life-threatening",
"Hospitalisation",
"Important Medical Event or Medical Treatment",
"Intensity Rating Scale:"
] |
NCT04823611 | B | 3 A Guide to Interpreting the Causality Question | B 3 A Guide to Interpreting the Causality Question When making an assessment of causality consider the following factors when deciding if there is a 'reasonable possibility' that an AE may have been caused by the drug. - Time Course. Exposure to suspect drug. Has the participant actually received the suspect drug? Did ... | [] |
NCT04823611 | B | 4 Medication Error | B 4 Medication Error For the purposes of this clinical study a medication error is an unintended failure or mistake in the treatment process for an AstraZeneca study intervention that either causes harm to the participant or has the potential to cause harm to the participant. A medication error is not lack of efficacy ... | [
"Appendix C Handling of Human Biological Samples"
] |
NCT04823611 | C | 1 Chain of Custody | C 1 Chain of Custody A full chain of custody is maintained for all samples throughout their lifecycle. The investigator at each centre keeps full traceability of collected biological samples from the participants while in storage at the centre until shipment or disposal (where appropriate) and records relevant processi... | [] |
NCT04823611 | C | 2 Withdrawal of Informed Consent for Donated Biological Samples | C 2 Withdrawal of Informed Consent for Donated Biological Samples If a participant withdraws consent to the use of donated biological samples, the samples will be disposed of/destroyed/repatriated, and the action documented. If samples are already analysed, AstraZeneca is not obliged to destroy the results of this rese... | [
"The investigator:"
] |
NCT04823611 | C | 3 International Airline Transportation Association 6.2 Guidance Document | C 3 International Airline Transportation Association 6.2 Guidance Document
LABELLING AND SHIPMENT OF BIOHAZARD SAMPLES International Airline Transportation Association (IATA) (https://www.iata.org/whatwedo/cargo/dgr/Pages/download.aspx) classifies infectious substances into 3 categories: Category A, Category B or Exem... | [
"LABELLING AND SHIPMENT OF BIOHAZARD SAMPLES",
"Appendix D Optional Genomics Initiative Sample"
] |
NCT04823611 | D | 1 Use/Analysis of DNA | D 1 Use/Analysis of DNA - AstraZeneca intends to collect and store DNA for genetic research to explore how genetic variations may affect clinical parameters, risk and prognosis of diseases, and the response to medications. This genetic research may lead to better understanding of diseases, better diagnosis of diseases ... | [] |
NCT04823611 | D | 2 Genetic Research Plan and Procedures | D 2 Genetic Research Plan and Procedures
Selection of Genetic Research Population All participants will be asked to participate in this genetic research. Participation is voluntary and if a participant declines to participate there will be no penalty or loss of benefit. The participant will not be excluded from any as... | [
"Selection of Genetic Research Population",
"Inclusion Criteria",
"Exclusion Criteria",
"Withdrawal of Consent for Genetic Research",
"Collection of Samples for Genetic Research",
"Coding and Storage of DNA Samples",
"Ethical and Regulatory Requirements",
"Informed Consent",
"Participant Data Protec... |
NCT04823611 | E | 1 Introduction | E 1 Introduction This Appendix describes the process to be followed in order to identify and appropriately report Potential Hy's Law (PHL) cases and HL cases. It is not intended to be a comprehensive guide to the management of elevated liver biochemistries. During the course of the study the investigator will remain vi... | [] |
NCT04823611 | E | 2 Definitions | E 2 Definitions
Potential Hy's Law AST or ALT ≥ 3 × ULN together with TBL≥ 2× ULN at any point during the study following the start of study medication irrespective of an increase in ALP.
Hy's Law AST or ALT ≥ 3× ULN together with TBL ≥ 2× ULN, where no other reason, other than the IMP, can be found to explain the co... | [
"Potential Hy's Law",
"Hy's Law"
] |
NCT04823611 | E | 3 Identification of Potential Hy's Law Cases | E 3 Identification of Potential Hy's Law Cases In order to identify cases of PHL it is important to perform a comprehensive review of laboratory data for any participant who meets any of the following identification criteria in isolation or in combination: - ALT ≥ 3 × ULN - AST ≥ 3 × ULN - TBL ≥ 2 × ULN
Central Labora... | [
"Central Laboratories Being Used:"
] |
NCT04823611 | E | 4 Follow-up | E 4 Follow-up | [] |
NCT04823611 | E | 4.1 Potential Hy's Law Criteria not met | E 4.1 Potential Hy's Law Criteria not met If the participant does not meet PHL criteria the investigator will: - Inform the AstraZeneca representative that the participant has not met PHL criteria. - Perform follow-up on subsequent laboratory results according to the guidance provided in the Clinical Study Protocol. | [] |
NCT04823611 | E | 4.2 Potential Hy's Law Criteria met | E 4.2 Potential Hy's Law Criteria met If the participant does meet PHL criteria the investigator will: - Determine whether PHL criteria were met at any study visit prior to starting study intervention. - Notify the AstraZeneca representative who will then inform the central Study Team - Within 1 day of PHL criteria bei... | [
"A 'significant' change in the participant's condition refers to a clinically relevant change in any of the individual liver biochemistry parameters (ALT, AST or total bilirubin) in isolation or in combination, or a clinically relevant change in associated symptoms. The determination of whether there has been a sig... |
NCT04823611 | E | 5 Review and Assessment of Potential Hy's Law Cases | E 5 Review and Assessment of Potential Hy's Law Cases The instructions in this Section should be followed for all cases where PHL criteria are met. As soon as possible after the biochemistry abnormality was initially detected, the Study Physician contacts the investigator in order to review available data and agree on ... | [] |
NCT04823611 | E | 6 Laboratory Tests | E 6 Laboratory Tests
Hy's Law Lab Kit for Central Laboratories | Additional standard chemistry and coagulation | GGT | |-----------------------------------------------|--------------------------------------------| | tests | LDH | | | Prothrombin time | | | INR | | Viral hepatitis | IgM anti-HAV | | | HBsAg | | | IgM a... | [
"Hy's Law Lab Kit for Central Laboratories"
] |
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