protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03268941 | 11.1.2 | Analysis of Demography and Other Baseline Characteristics | 11.1.2 Analysis of Demography and Other Baseline Characteristics Demographic and baseline characteristics will be summarized by treatment and overall for all subjects in the safety set. Summary statistics (number of subjects, mean, SD, median, minimum, and maximum) will be presented for continuous variables (eg, age, w... | [] |
NCT03268941 | 11.1.3 | PK Analysis | 11.1.3 PK Analysis Concentrations of TAK-906 will be summarized by treatment over each scheduled sampling time. Individual plasma concentration versus time data will be presented in a data listing. Plasma PK parameters of TAK-906 will be summarized by treatment using descriptive statistics. A more detailed analysis wil... | [] |
NCT03268941 | 11.1.4 | PD Analysis | 11.1.4 PD Analysis For each of the following (ie, change in prolactin, change in GEBT gastric half-emptying time, change in SmartPill GE time, endpoints), a linear model will be fit; the model will include fixed effects of stratification factor, regimen (dose level), a random effect of subject, and a covariate of basel... | [] |
NCT03268941 | 11.1.5 | Safety Analysis | 11.1.5 Safety Analysis The safety set will be used for all summaries of safety parameters. These summaries will be presented by treatment. | [] |
NCT03268941 | 11.1.5.1 | AEs | 11.1.5.1 AEs All AEs will be coded by system organ class (SOC) and preferred term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse events (TEAEs) with onset occurring within 30 days after the last dose of trial drug (onset date minus last date of dose +1≤30) will be inclu... | [] |
NCT03268941 | 11.1.5.2 | Clinical Laboratory Evaluation | 11.1.5.2 Clinical Laboratory Evaluation Baseline, postdose, and change from Baseline to postdose laboratory data will be summarized by treatment. Individual results of laboratory tests from hematology, chemistry, and urinalysis that meet Takeda's markedly abnormal criteria will be summarized. All clinical laboratory da... | [] |
NCT03268941 | 11.1.5.3 | Vital Signs | 11.1.5.3 Vital Signs Baseline, postdose, and changes from Baseline in vital sign measurements will be summarized. Individual results of vital signs that meet Takeda's markedly abnormal criteria will be summarized. All vital sign data will be provided in the data listings. | [] |
NCT03268941 | 11.1.5.4 | Other Safety Parameters | 11.1.5.4 Other Safety Parameters Baseline, postdose, and changes from Baseline in quantitative ECG parameters will be summarized by treatment. Shift tables for each will be generated to show the investigator's ECG interpretations at each postdose collection by the interpretation at Baseline. Individual results of quant... | [] |
NCT03268941 | 11.2 | Interim Analysis and Criteria for Early Termination | 11.2 Interim Analysis and Criteria for Early Termination No formal interim analyses will be conducted. | [] |
NCT03268941 | 11.3 | Determination of Sample Size | 11.3 Determination of Sample Size Assuming an SD of 20% for the percent change from Baseline in half-emptying time, a total of approximately 48 subjects (12 per treatment group) is sufficient to achieve around 80% power to detect a difference of 25% between TAK-906 doses and placebo in the GEBT by a 2-sample t-test wit... | [] |
NCT03268941 | 12.0 | QUALITY CONTROL AND QUALITY ASSURANCE | 12.0 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT03268941 | 12.1 | Study-Site Monitoring Visits | 12.1 Study-Site Monitoring Visits Monitoring visits to the study site will be made periodically during the study to ensure that all aspects of the protocol are followed. Source documents will be reviewed for verification of data recorded on the eCRFs. Source documents are defined as original documents, data, and record... | [] |
NCT03268941 | 12.2 | Protocol Deviations | 12.2 Protocol Deviations The investigator should not deviate from the protocol, except where necessary to eliminate an immediate hazard to trial subjects. Should other unexpected circumstances arise that will require deviation from protocol-specified procedures, the investigator should consult with the sponsor or desig... | [] |
NCT03268941 | 12.3 | Quality Assurance Audits and Regulatory Agency Inspections | 12.3 Quality Assurance Audits and Regulatory Agency Inspections The study site also may be subject to quality assurance audits by the sponsor or designees. In this circumstance, the sponsor-designated auditor will contact the site in advance to arrange an auditing visit. The auditor may ask to visit the facilities wher... | [] |
NCT03268941 | 13.0 | ETHICAL ASPECTS OF THE STUDY | 13.0 ETHICAL ASPECTS OF THE STUDY This study will be conducted with the highest respect for the individual participants (ie, subjects) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the International Conference on Harmonisation (ICH) Harmonised Tripartite Gu... | [] |
NCT03268941 | 13.1 | IRB and/or IEC Approval | 13.1 IRB and/or IEC Approval IRBs and IECs must be constituted according to the applicable state and federal/local requirements of each participating region. The sponsor or designee will require documentation noting all names and titles of members who make up the respective IRB or IEC. If any member of the IRB or IEC h... | [] |
NCT03268941 | 13.2 | Subject Information, Informed Consent, and Subject Authorization | 13.2 Subject Information, Informed Consent, and Subject Authorization Written consent documents will embody the elements of informed consent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and regulations. The informed consent form, subject a... | [] |
NCT03268941 | 13.3 | Subject Confidentiality | 13.3 Subject Confidentiality The sponsor and designees affirm and uphold the principle of the subject's right to protection against invasion of privacy. Throughout this study, a subject's source data will only be linked to the sponsor's clinical study database or documentation via a unique identification number. As per... | [] |
NCT03268941 | 13.4 | Publication, Disclosure, and Clinical Trial Registration Policy | 13.4 Publication, Disclosure, and Clinical Trial Registration Policy | [] |
NCT03268941 | 13.4.1 | Publication and Disclosure | 13.4.1 Publication and Disclosure The investigator is obliged to provide the sponsor with complete test results and all data derived by the investigator from the study. During and after the study, only the sponsor may make study information available to other study investigators or to regulatory agencies, except as req... | [] |
NCT03268941 | 13.4.2 | Clinical Trial Registration | 13.4.2 Clinical Trial Registration In order to ensure that information on clinical trials reaches the public in a timely manner and to comply with applicable laws, regulations and guidance, Takeda will, at a minimum register all interventional clinical trials it sponsors anywhere in the world on ClinicalTrials.gov and/... | [] |
NCT03268941 | 13.4.3 | Clinical Trial Results Disclosure | 13.4.3 Clinical Trial Results Disclosure Takeda will post the results of clinical trials on ClinicalTrials.gov or other publicly accessible websites, as required by Takeda Policy/Standard, applicable laws and/or regulations. | [] |
NCT03268941 | 13.5 | Insurance and Compensation for Injury | 13.5 Insurance and Compensation for Injury Each subject in the study must be insured in accordance with the regulations applicable to the site where the subject is participating. If a local underwriter is required, then the sponsor or sponsor's designee will obtain clinical study insurance against the risk of injury to... | [] |
NCT03268941 | 14.0 | ADMINISTRATIVE AND REFERENCE INFORMATION | 14.0 ADMINISTRATIVE AND REFERENCE INFORMATION | [] |
NCT03268941 | 14.1 | Administrative Information | 14.1 Administrative Information | [] |
NCT03268941 | 14.1.1 | Study Contact Information | 14.1.1 Study Contact Information | Contact Type / Role | Contact | |-----------------------------|----------------------------------| | SAE and pregnancy reporting | Company Confidential Information | | | | | [] |
NCT03268941 | 14.1.2 | INVESTIGATOR AGREEMENT | 14.1.2 INVESTIGATOR AGREEMENT I confirm that I have read and that I understand this protocol, the Investigator's Brochure, package insert and any other product information provided by the sponsor. I agree to conduct this study in accordance with the requirements of this protocol and also to protect the rights, safety, ... | [] |
NCT03268941 | 14.1.3 | Study-Related Responsibilities | 14.1.3 Study-Related Responsibilities The sponsor will perform all study-related activities with the exception of those identified in the Study-Related Responsibilities template. The vendors identified for specific study-related activities will perform these activities in full or in partnership with the sponsor. | [] |
NCT03268941 | 14.1.4 | List of Abbreviations | 14.1.4 List of Abbreviations AE adverse event ALT alanine aminotransferase Confidential Information AST aspartate aminotransferase AUC∞ area under the concentration-time curve from time 0 to infinity, calculated using the observed value of the last quantifiable concentration AUCτ area under the concentration-time curve... | [
"CONFIDENTIAL",
"Protocol Incorporating Amendment No. 04 14 December 2017"
] |
NCT03268941 | 15.0 | DATA HANDLING AND RECORDKEEPING | 15.0 DATA HANDLING AND RECORDKEEPING The full details of procedures for data handling will be documented in the Data Management Plan. AEs, medical history, and concurrent conditions will be coded using MedDRA. Drugs will be coded using the World Health Organization Drug Dictionary. | [] |
NCT03268941 | 15.1 | CRFs (Electronic and Paper) | 15.1 CRFs (Electronic and Paper) Completed eCRFs are required for each subject who signs an informed consent. The sponsor or its designee will supply investigative sites with access to eCRFs. The sponsor will make arrangements to train appropriate site staff in the use of the eCRF. These forms are used to transmit the ... | [] |
NCT03268941 | 15.2 | Record Retention | 15.2 Record Retention The investigator agrees to keep the records stipulated in Section [15.1](#page-69-1) and those documents that include (but are not limited to) the study-specific documents, the identification log of all participating subjects, medical records, temporary media such as thermal sensitive paper, sourc... | [] |
NCT03268941 | 16.0 | REFERENCES | 16.0 REFERENCES - 1. Parkman HP, Hasler WL, Fisher RS, American Gastroenterological A. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology 2004;127(5):1592-622. - 2. Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L, American College of G. Clin... | [] |
NCT03268941 | 17.0 | APPENDICES | 17.0 APPENDICES
Appendix A Detailed Description of Amendments to Text The primary section(s) of the protocol affected by the changes in Amendment No. 04 are indicated. The corresponding text has been revised throughout the protocol. Change [1:](#page-9-1) [Changed the body mass index criteria for eligibility.](#page-9... | [
"Appendix A Detailed Description of Amendments to Text",
"Rationale for Change:",
"Appendix B Responsibilities of the Investigator",
"Appendix C Elements of the Subject Informed Consent",
"Appendix D Investigator Consent to the Use of Personal Information",
"Appendix E Pregnancy and Contraception",
"Pre... |
NCT03277261 | 1 | Subject Reported Relapse | 1. Subject Reported Relapse Subjects who experience new or worsening neurologic symptoms are instructed to contact the Treating Neurologist within 48 hours of symptom onset. All new or worsening neurological events, reported at a visit or over the phone, consistent with MS representing a clinical relapse as assessed by... | [] |
NCT03277261 | 2 | Initial Assessment of Relapse by Treating Neurologist and Examining Neurologist | 2. Initial Assessment of Relapse by Treating Neurologist and Examining Neurologist The Treating Neurologist will perform a neurological and physical examination and safety assessment. The Treating Neurologist or designee will document in the eCRF the following: o Time and date of neurological and physical examination -... | [] |
NCT03277261 | 3 | Confirmation of Relapse by IRAP | 3. Confirmation of Relapse by IRAP All assessments entered into the eCRF from both the Treating Neurologist and the blinded Examining Neurologist, will be sent to an Independent Relapse Adjudication Panel (IRAP). IRAP adjudicates each case based on all available data provided for that case and members are not permitted... | [
"Re-consent criteria after relapse",
"Disability Progression",
"Ublituximab/oral placebo vs Teriflunomide/IV placebo Regimen (please see dosing regimen below)",
"Abbreviated Blood Sample Assessment Schedule (for further details see Section 6):",
"PROTOCOL SCHEMA",
"Phase III",
"LIST OF ABBREVIATIONS",
... |
NCT03277261 | 3.1 | INCLUSION CRITERIA | 3.1 INCLUSION CRITERIA Subjects must meet the following inclusion criteria to be eligible for participation in this study: - 1. 18-55 age - 2. Diagnosis of RMS (McDonald criteria 2010; Appendix C) - 3. ≥ 2 relapses in prior 2 years or 1 relapse in the year prior to screening and/or ≥1 Gd enhancing lesion - 4. Documente... | [] |
NCT03277261 | 3.2 | EXCLUSION CRITERIA | 3.2 EXCLUSION CRITERIA Subjects who meet any of the following exclusion criteria are not to be enrolled to this study: - 1. Treatment with Anti-CD20 or other B cell directed treatment - 2. Treatment with the following therapies at any time prior to randomization: - Alemtuzumab - Natalizumab, - Teriflunomide, - Leflunom... | [] |
NCT03277261 | 3.3 | DISCONTINUATION FROM STUDY TREATMENT | 3.3 DISCONTINUATION FROM STUDY TREATMENT Subjects will be discontinued from trial treatment or withdrawn from the study for any of the following reasons: - Irreversible or intolerable toxicity or abnormal laboratory values thought to be related to drug toxicity - Subject requests to withdraw consent or discontinue trea... | [
"PREGNANCY"
] |
NCT03277261 | 4.1 | DEFINITION OF STUDY STAFF | 4.1 DEFINITION OF STUDY STAFF
AT THE STUDY SITE At each study center the staff will consist of a minimum of two neurologists. One neurologist will be the Treating Neurologist and one will be the Examining Neurologist for a given subject throughout the study. An MRI radiologist and technologist, and a clinical coordina... | [
"AT THE STUDY SITE",
"PRINCIPAL INVESTIGATOR",
"TREATING NEUROLOGIST",
"EXAMINING NEUROLOGIST (EVALUATING NEUROLOGIST)",
"MRI STAFF",
"CLINICAL COORDINATOR"
] |
NCT03277261 | 4.2 | STUDY COMMITTEES | 4.2 STUDY COMMITTEES
DATA SAFETY MONITORING BOARD (DSMB) The DSMB will be an independent group of individuals not involved in the study or study sites or have other conflicts of interest with the study and are charged with reviewing safety data and conduct of the trial. The independent DSMB will be comprised of five m... | [
"DATA SAFETY MONITORING BOARD (DSMB)"
] |
NCT03277261 | 4.2.2 | STEERING COMMITTEE | 4.2.2 STEERING COMMITTEE An external Steering Committee will provide general guidance, assist with liaison to investigators and oversee some external communication of the results of the study. | [] |
NCT03277261 | 4.2.3 | INDEPENDENT RELAPSE ADJUDICATION PANEL (IRAP) | 4.2.3 INDEPENDENT RELAPSE ADJUDICATION PANEL (IRAP) The IRAP will make all protocol-defined relapse determinations in this study. The IRAP will review all subjectreported, suspected, on-study relapses (i.e., new or worsening neurological symptoms) and all potential events are sent to the IRAP regardless of whether the ... | [] |
NCT03277261 | 4.2.4 | BLINDED ASSESSMENT RELAPSE TEAM (BART) | 4.2.4 BLINDED ASSESSMENT RELAPSE TEAM (BART) An independent committee, Blinded Assessment Relapse Team (BART), reporting to TG Therapeutics, and the DSMB will reassess the sample size for the study when 210 of the 220 participants in each arm have been randomized. Team will consist of a chair, 1 biostatistician and 1 o... | [] |
NCT03277261 | 4.3 | DOSING SCHEMA | 4.3 DOSING SCHEMA Table 3: Ublituximab/Oral Placebo and Teriflunomide (14 mg)/IV Placebo | Table 3: Ublituximab/Oral Placebo and Teriflunomide (14 mg)/IV Placebo | | | | | | | |------------------------------------------------------------------------|---------------------------------|------------------------------------... | [] |
NCT03277261 | 4.3.1 | STOPPING RULES | 4.3.1 STOPPING RULES There are no pre-planned interim analyses planned with formal stopping rules for effectiveness. The DSMB may make recommendations to stop the trial and will provide their rationale justification along with such a recommendation as will be specified in the DSMB Charter. | [] |
NCT03277261 | 4.4 | GENERAL CONCOMITANT MEDICATION AND SUPPORTIVE CARE GUIDELINES | 4.4 GENERAL CONCOMITANT MEDICATION AND SUPPORTIVE CARE GUIDELINES The following treatments are prohibited while on clinical trial: other investigational drug treatments or interventional study participation, other DMTs used to treat MS, radiation therapy, hormonal therapy for cancer, cancer immunotherapy or other biolo... | [
"MS RELAPSE DURING THE STUDY",
"MS Relapses During the Study",
"1. Subject Reported Relapse",
"2. Initial Assessment of Relapse by Treating Neurologist and Examining Neurologist",
"3. Confirmation of Relapse by IRAP",
"TREATING NEUROLOGIST MEDICALLY CONFIRMED RELAPSE",
"RE-CONSENT CRITERIA AFTER RELAPSI... |
NCT03277261 | 4.5 | DURATION OF THERAPY | 4.5 DURATION OF THERAPY For subjects randomized to ublituximab or treated with IV placebo, infusion will occur on Week 1 Day 1, Week 3 Day 15, and Weeks 24, 48 and 72. For subjects randomized to teriflunomide or treated with oral placebo, administration may be taken in the morning until the last day of Week 95. Alterna... | [] |
NCT03277261 | 4.6 | SUBJECT RETENTION STRATEGIES | 4.6 SUBJECT RETENTION STRATEGIES Understanding adherence to pharmacotherapies is crucial in clinical practice and research studies to ensure optimal clinical outcomes and valid study results. Thus, subject adherence can apply to several different clinical trial facets that may include adherence to study procedures, stu... | [] |
NCT03277261 | 5.1 | CRITERIA FOR ONGOING TREATMENT | 5.1 CRITERIA FOR ONGOING TREATMENT Repeat treatment of ublituximab/oral placebo or teriflunomide/IV placebo should be administered per protocol provided that: - \ Renal function is continually assessed - e Liver enzyme levels are monitored monthly for the first 6 months e Recovered from Grade 3-4 non-hematologic toxici... | [] |
NCT03277261 | 5.2 | GUIDANCE FOR SUSPECTED RELAPSE | 5.2 GUIDANCE FOR SUSPECTED RELAPSE If a subject experiences a suspected relapse at any study visit after the 1st dose of either study medication, the following actions are to be taken: | At Scheduled Infusion Visit | Perform an unscheduled relapse visit and do not performthe infusion visit. The scheduled infusion visit... | [] |
NCT03277261 | 5.3 | GUIDANCE FOR LABORATORY ABNORMALITIES | 5.3 GUIDANCE FOR LABORATORY ABNORMALITIES For RMS subjects, the hematologic dose modifications are graded by the CTCAE (https://evs.ncinih.gov/ftp1/CTCAE/CTCAE 4.03 2010-06-14 QuickReference 5x7.pdf). v4.03 If a subject experiences neutropenia, thrombocytopenia, anemia, and elevated liver enzymes at any study visit aft... | [] |
NCT03277261 | 6 | SCHEDULE OF ASSESSMENTS AND PROCEDURES | 6 SCHEDULE OF ASSESSMENTS AND PROCEDURES Individual trial procedures are detailed in Tables 5-7. It may be necessary to perform these procedures at unscheduled time points if deemed clinically necessary by the Treating and Examining Neurologists. Additional evaluations/testing may be deemed necessary by the Treating Ne... | [] |
NCT03277261 | 6.2 | LABORATORY EVALUATION | 6.2 LABORATORY EVALUATION - 1. Hematologic profile: CBC/FBC with differential and platelet count should be obtained at: - a. Forall subjects: - i. Blood collection for CBC at screening, and Week 1 Day 1 (pre-dose), Day 2, Day 8, Week 3 Day 15 (pre-dose), and Weeks 4, 8, 12, 16, 20, 24 (pre-dose), 36, 48 (pre-dose) 60, ... | [] |
NCT03277261 | 7 | Fibrinogen tests | 7. Fibrinogen tests - a. All subjects will have 5 serum samples taken prior to the infusions on Week 1 Day 1, Week 3 Day 15 and Weeks 24, 48, and 72. Additionally, fibrinogen will be analyzed for subjects who withdraw from treatment early or have an Unscheduled Relapse Visit. - 8. Anti-Drug Antibody (antibodies develop... | [] |
NCT03277261 | 10 | Plasma concentration for teriflunomide | 10. Plasma concentration for teriflunomide - a. In order to assess teriflunomide compliance, four plasma samples will be taken from all subjects. The first sample will be taken prior to oral administration of teriflunomide or oral placebo on Week 1 Day 1. The second sample will be taken prior to infusion of ublituximab... | [
"6.3 CLINICAL ASSESSMENT AND PROCEDURES",
"ASSESSMENT OF RELAPSE",
"MS Relapses During the Study",
"1. Subject Reported Relapse",
"2. Initial Assessment of Relapse by Treating Neurologist and Examining Neurologist",
"3. Confirmation of Relapse by IRAP",
"Treating Neurologist Medically Reported Relapse",... |
NCT03277261 | 10 | STOPPING RULES | 10 STOPPING RULES The DSMB (Study Chairs, Medical Monitor and Sponsor Representative) will be in charge of reviewing safety data. These events will be reviewed by the DSMB and potentially other study investigators during the course of the study. All other serious and non-serious adverse events will be documented, manag... | [] |
NCT03277261 | 11 | ETHICAL, FINANCIAL, AND REGULATORY CONSIDERATIONS | 11 ETHICAL, FINANCIAL, AND REGULATORY CONSIDERATIONS This trial will be conducted according to the standards of Good Clinical Practice outlined in the ICH E6 Tripartite Guideline and CFR Title 21 part 312, applicable government regulations, institutional research policies and procedures and any other local applicable r... | [] |
NCT03277261 | 11.1 | IRB/EC APPROVAL | 11.1 IRB/EC APPROVAL The trial protocol, ICF, IBs, available safety information, subject documents (e.g., trial diary), subject recruitment procedures (e.g., advertisements), information about payments (i.e., PI payments) and compensation available to the subjects and documentation evidencing the PI's qualifications mu... | [] |
NCT03277261 | 11.2 | REGULATORY APPROVAL | 11.2 REGULATORY APPROVAL As required by local regulations, the Sponsor will ensure all legal aspects are covered, and approval of the appropriate regulatory bodies obtained, prior to trial initiation. If required, the Sponsor will also ensure that the implementation of substantial amendment to the protocol and other re... | [] |
NCT03277261 | 11.3 | INSURANCE AND INDEMNITY | 11.3 INSURANCE AND INDEMNITY Details of insurance and/or indemnity will be contained within the written agreement between the PI or site and the Sponsor. | [] |
NCT03277261 | 11.4 | INFORMED CONSENT | 11.4 INFORMED CONSENT Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written... | [] |
NCT03277261 | 11.5 | CONFIDENTIALITY | 11.5 CONFIDENTIALITY
Subject Confidentiality Confidentiality of subject's personal data will be protected in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA; for USA only), and national data protection laws. HIPAA regulations require that, in order to participate in the trial, a ... | [
"Subject Confidentiality"
] |
NCT03277261 | 11.6 | INVESTIGATOR AND STAFF INFORMATION | 11.6 INVESTIGATOR AND STAFF INFORMATION Personal data of the investigators and sub-investigators may be included in the Sponsor database, and shall be treated in compliance with all applicable laws and regulations. When archiving or processing personal data pertaining to the investigator or sub-investigator, the Sponso... | [] |
NCT03277261 | 11.7 | FINANCIAL INFORMATION | 11.7 FINANCIAL INFORMATION The finances for this trial will be subject to a separate written agreement between the Sponsor and/or designee and applicable parties. Any Investigator financial disclosures as applicable to 21CFR Part 54 shall be appropriately provided. TG1101-RMS301 Dated: 04 September 2020 (Ver. 5.0) Page... | [] |
NCT03277261 | 12 | RECORD RETENTION AND DOCUMENTATION OF THE TRIAL | 12 RECORD RETENTION AND DOCUMENTATION OF THE TRIAL | [] |
NCT03277261 | 12.1 | AMENDMENTS TO THE PROTOCOL | 12.1 AMENDMENTS TO THE PROTOCOL Amendments to the protocol shall be planned, documented and signature authorized prior to implementation. If an amendment to the protocol is required, the amendment will be originated and documented by the Sponsor. All amendments require review and approval of the Sponsor. The written am... | [] |
NCT03277261 | 12.2 | DOCUMENTATION REQUIRED TO INITIATE TRIAL | 12.2 DOCUMENTATION REQUIRED TO INITIATE TRIAL Before the trial may begin, documentation required by FDA regulations must be provided by the Investigator. The required documentation should be submitted to the Sponsor or designee. Documents at a minimum required to begin the trial include, but are not limited to, the fol... | [] |
NCT03277261 | 12.3 | TRIAL DOCUMENTATION AND STORAGE | 12.3 TRIAL DOCUMENTATION AND STORAGE The PI must maintain a list of appropriately qualified persons to whom he/she has delegated trial duties and should ensure that all persons assisting in the conduct of the trial are informed of their obligations. All persons authorized to make entries and/or corrections on the eCRFs... | [] |
NCT03277261 | 12.4 | DATA COLLECTION | 12.4 DATA COLLECTION The trial eCRF is the primary data collection instrument for the trial. An electronic Case Report Form (eCRF) will be utilized for the collection of all data and all data will be entered using the English language and should be kept current to enable the monitor to review the subjects' status throu... | [] |
NCT03277261 | 12.5 | TRIAL MONITORING, AUDITING, AND INSPECTING | 12.5 TRIAL MONITORING, AUDITING, AND INSPECTING The investigator will permit trial-related monitoring, quality audits, and inspections by the government Regulatory Authorities, the Sponsor or its representative(s) of all trial-related documents (e.g., source documents, regulatory documents, data collection instruments,... | [] |
NCT03277261 | 12.6 | QUALITY ASSURANCE AND QUALITY CONTROL | 12.6 QUALITY ASSURANCE AND QUALITY CONTROL In addition to the Clinical Monitoring component of this protocol, the Sponsor's Quality Assurance (QA) department shall establish an Auditing Plan document separate from the protocol to establish the criteria by which independent auditing shall be conducted during the conduct... | [] |
NCT03277261 | 12.7 | DISCLOSURE AND PUBLICATION POLICY | 12.7 DISCLOSURE AND PUBLICATION POLICY All information provided regarding the trial, as well as all information collected/documented during the course of the trial, will be regarded as confidential. The Sponsor reserves the right to release literature publications based on the results of the trial. A Clinical Study Rep... | [] |
NCT03277261 | 13 | REFERENCES | 13 REFERENCES - 1. http://www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic (Assessed June 11, 2015) - 2. Lublin FD et al. Neurology. 1996 ;46 :907-911. - 3. Lublin FD et al. Neurology. 2014 ; 83 :278-286. - 4. Polman C et al. NEJM. 2006 ; 354(9) :889-910. - 5. de Romeuf C, Dutertre CA, Le Garff... | [
"Women Not of Childbearing Potential are Defined as Follows:",
"Contraceptive Guidelines for Women of Child-Bearing Potential:",
"Fertile Males:",
"Pregnancies"
] |
NCT03277261 | 15 | APPENDIX B; NYHA CLASSIFICATIONS | 15 APPENDIX B; NYHA CLASSIFICATIONS
New York Heart Association (NYHA) Classifications | Class | Functional Capacity | Objective Assessment | |-------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [
"New York Heart Association (NYHA) Classifications"
] |
NCT03277261 | 16 | APPENDIX C; 2010 MCDONALD DIAGNOSTIC CRITERIA FOR MS | 16 APPENDIX C; 2010 MCDONALD DIAGNOSTIC CRITERIA FOR MS | [] |
NCT03277261 | 2010 | Revised McDonald Diagnostic Criteria for MS [12] | 2010 Revised McDonald Diagnostic Criteria for MS [12] | Clinical (Attacks) | Lesions | Additional Criteria to Make | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------... | [
"What is an attack?",
"Provides Evidence for Dissemination in Space (DIS)?",
"What provides MRI Evidence of Dissemination in Time (DIT)?",
"17 APPENDIX D; INDEPENDENT RELAPSE ADJUDICATION PANEL (IRAP)",
"Independent Relapse Adjudication Panel (IRAP)",
"18 APPENDIX E: EVALUATION PROCEDURE FOR SUBJECT REPOR... |
NCT03278067 | 1 | SYNOPSIS | 1. SYNOPSIS
Background: The European Medicines Agency (EMA) set out new requirements for influenza vaccine safety surveillance that all Marketing Authorisation Holders (MAHs) providing vaccines in the EU must address. The EMA guideline came into effect in February 2017 and included its last Pharmacovigilance Risk Asse... | [
"Background:",
"Aim:",
"Objectives:",
"Method:",
"Outputs:"
] |
NCT03278067 | 2 | LIST OF ABBREVIATIONS AND GLOSSARY | 2. LIST OF ABBREVIATIONS AND GLOSSARY | ADR | Adverse drug reaction | |-------------|----------------------------------------------------------------------------------------| | AEFI | Adverse events following immunization | | AEI | Adverse events of interest – as defined by EMA for this report | | BMI | Body Mass Index... | [] |
NCT03278067 | 207781 | (EPI-FLU-055 VS UK) | 207781 (EPI-FLU-055 VS UK)
Final Protocol | RCGP RSC | Royal College of General Practitioners Research and Surveillance Centre | |----------|------------------------------------------------------------------------------------------------| | RSC | Research and Surveillance Centre (part of RCGP) | | REC | Research Ethic... | [
"Final Protocol",
"3. RESPONSIBLE SPONSORS",
"University of Surrey",
"GSK Vaccines",
"4. INTRODUCTION",
"a. Rationale for the pilot study and background",
"The UK national flu immunisation programme 2017/18 – recommendations",
"b. Objectives and endpoints",
"Primary objective:",
"Secondary objecti... |
NCT03278067 | 207781 | (EPI-FLU-055 VS UK) | 207781 (EPI-FLU-055 VS UK)
Final Protocol | ExpectedPopulationmedicallyfollowed bythe enrolledpractices | Vaccinecoverage | Vaccinatedsubjects | Subjectswithevents | ExpectedProportionof subjectswith ≥1 AEIreported | Lower95%CL | Upper95%CL | Probabilityto observe≥1 AEI in thestudypopulation | AssociatedRelativestanda... | [
"Final Protocol",
"Statistical analyses",
"Sequence of analysis",
"Interim analysis",
"Weekly safety report",
"Final analysis after end of the surveillance period",
"Analyses of demographics/baseline characteristics",
"Analyses of the primary objective",
"The weekly incidence rates (per 100 subjects... |
NCT03278067 | 207781 | (EPI-FLU-055 VS UK) Final Protocol | 207781 (EPI-FLU-055 VS UK) Final Protocol Information Sheet for GP practices Version 1-May 15" 2017 NHS Health and Social Care Information Centre (HSCIC). Details of the departmental information governance policies and procedures can be found in: hittp://www.clininf.eu/about/information-governance.html
Why have | heen... | [
"Why have | heen invited to take part?",
"What will happen if| take part?",
"What are my responsibilities?",
"What are the possible benefits of taking part?",
"Appendix 6 Information Sheet - Patients",
"Appendix 7 Practice feedback sample",
"Appendix 8 Practice consent form",
"Agreement to participate... |
NCT03340883 | A | Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults with Relapsed or Refractory Multiple Myeloma | A Phase 1/2, Dose Escalation, Safety and Tolerability Study of BION-1301 in Adults with Relapsed or Refractory Multiple Myeloma Protocol Number: ADU-CL-16 Original Protocol: 04 August 2017 Amendment 1: 28 September 2017 Amendment 2: 13 November 2018 Investigational Product: BION-1301 (humanized IgG4 anti-a proliferatio... | [
"Confidentiality Statement",
"2 SYNOPSIS",
"INVESTIGATIONAL PRODUCT:",
"OBJECTIVES:",
"ENDPOINTS:",
"Phase 1",
"Phase 2",
"Exploratory Endpoints evaluated throughout the study as appropriate include:",
"STUDY DESIGN:",
"ADU-CL-16 Study Schema",
"DURATION OF SUBJECT PARTICIPATION:",
"STUDY POPU... |
NCT03343626 | 2.0 | Interim Analysies: | 2.0 Interim Analysies: A first interim analysis will be performed to include immunogenicity and safety data from all flavivirus naïve subjects up to Visit 6 (on Day 57, 28 days post dose 2); a second interim analysis will be performed for dose selection, and including safety data from all flavivirus primed subjects up ... | [
"Final Analysis:"
] |
NCT03343626 | 2.0 | TRIAL SUMMARY | 2.0 TRIAL SUMMARY | Takeda Vaccines, Inc. | Product Name: | |----------------------------|----------------------------------------------------------| | 40 Landsdowne Street | Purified Inactivated Zika Virus Vaccine (PIZV) candidate | | Cambridge, MA 02139USA | (TAK-426) | Trial Title: A Phase 1, Randomized, Observer-Bl... | [
"Background and Rationale:",
"stratification of randomization.",
"Trial Design:",
"Primary Objectives",
"Secondary Objectives",
"Criteria for Inclusion:",
"Criteria for Exclusion:",
"Trial Vaccines:",
"Investigational Vaccine:",
"Placebo:",
"Duration of the Trial: Approximately 7 or 25 months, f... |
NCT03343626 | 2.1 | Schedule of Trial Procedures | 2.1 Schedule of Trial Procedures | | Schedule of Trial Procedures | | | | | | | | | blea | Ter | | | |-----------------------------------------------------------------------------------------------------|------------------------------|---------------------------|----------|---------------------|------------------------... | [] |
NCT03343626 | 3.0 | TRIAL REFERENCE INFORMATION | 3.0 TRIAL REFERENCE INFORMATION | [] |
NCT03343626 | 3.1 | Trial-Related Responsibilities | 3.1 Trial-Related Responsibilities The sponsor will perform all trial-related activities with the exception of those identified in the Trial-Related Responsibilities template. The identified vendors in the template for specific trial-related activities will perform these activities in full or in partnership with the sp... | [] |
NCT03343626 | 3.2 | Principal Investigator/Coordinating Investigator | 3.2 Principal Investigator/Coordinating Investigator The sponsor will select a Signatory Principal Investigator / Coordinating Investigator from the investigators who participate in the trial. Selection criteria for this investigator will include significant knowledge of the trial protocol, the investigational vaccine,... | [] |
NCT03343626 | 3.3 | List of Abbreviations | 3.3 List of Abbreviations ADE Antibody-Dependent Enhancement AE Adverse Event BARDA Biomedical Advanced Research and Development Authority BMI Body Mass Index CI Confidence Interval CNS Central Nervous System CRO Contract Research Organization CZS Congenital Zika Syndrome DENV Dengue Virus DMC Data Monitoring Committee... | [] |
NCT03343626 | 3.4 | Corporate Identification Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use | 3.4 Corporate Identification Property of Takeda: For Non-Commercial Use Only and Subject to the Applicable Terms of Use Not applicable. | [] |
NCT03343626 | 4.0 | INTRODUCTION | 4.0 INTRODUCTION | [] |
NCT03343626 | 4.1 | Background | 4.1 Background | [] |
NCT03343626 | 4.1.1 | Zika Virus | 4.1.1 Zika Virus Zika virus (ZIKV) is a mosquito-borne single-stranded positive-sense ribonucleic acid (RNA) virus (11 kb in size) (26) which belongs to the Flaviviridae family, genus Flavivirus, that often causes no or only mild symptoms, including a rash and a febrile flu-like illness in the majority of symptomatic i... | [] |
NCT03343626 | 4.1.2 | Epidemiology | 4.1.2 Epidemiology The first large outbreak of ZIKV disease was reported in Yap Island (Federal state of Micronesia) in 2007 (33), and was followed by an outbreak in French Polynesia in 2013-2014 (34). The first cases of ZIKV disease in South America were reported in Easter Island in 2014 (35), and the first reports of... | [] |
NCT03343626 | 4.1.3 | Transmission | 4.1.3 Transmission The primary mode of transmission of ZIKV is through the bite of female mosquitoes, prominently Aedes aegypti and Ae. albopictus species that have spread globally (39). Other potential vectors for ZIKV include other Aedes species (including Ae. furcifer, Ae. vittatus, Ae. dalzieli, Ae. metallicus, Ae.... | [] |
NCT03343626 | 4.1.4 | ZIKV Infection: Detection, Disease, Complications and Treatment | 4.1.4 ZIKV Infection: Detection, Disease, Complications and Treatment
Detection Testing for ZIKV infection is complicated by the temporal appearance and disappearance of biologic analytes in the infected person and thus multiple tests and sample types are often needed to establish a definitive laboratory diagnosis of ... | [
"Detection",
"Disease",
"Congenital Zika Syndrome",
"Guillain-Barré Syndrome",
"Treatment"
] |
NCT03343626 | 4.2 | Rationale for the Proposed Trial e | 4.2 Rationale for the Proposed Trial e | [] |
NCT03343626 | 4.2.1 | Medical Need | 4.2.1 Medical Need ZIKV has posed a challenging situation for health, public and economic sectors of affected countries. The increase in microcephaly cases and other neurological disorders reported in Brazil following a similar cluster in the French Polynesia in 2014 (24), prompted the World Health Organization (WHO) t... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.