protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02531633 | 12.2.2 | Collection of Pregnancy Information | - Investigator will collect pregnancy information on any female subject or female partner of male study subject who becomes pregnant while participating in or while partner is participating in this study.
- Information will be recorded on the appropriate form and submitted to GSK within 2 weeks of learning of a subject... | [] |
NCT02531633 | 12.3 | Appendix 3: Liver Safety Required Actions and Follow up Assessments | Phase III-IV liver chemistry stopping and increased monitoring criteria have been designed to assure subject safety and evaluate liver event etiology (in alignment with the FDA premarketing clinical liver safety guidance).
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid ances/UCM174090.... | [
"MONITORING:",
"For bilirubin or INR criteria:",
"For All other criteria:",
"For bilirubin or INR criteria:",
"Phase III-IV liver chemistry increased monitoring criteria with continued therapy",
"References"
] |
NCT02531633 | 12.4 | Appendix 4: Definition of and Procedures for Recording, Evaluating, Follow-Up and Reporting of Adverse Events | [] | |
NCT02531633 | 12.4.1 | Definition of Adverse Events |
- An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding... | [
"Adverse Event Definition:",
"Events meeting AE definition include:",
"Events NOT meeting definition of an AE include:"
] |
NCT02531633 | 12.4.2 | Definition of Serious Adverse Events | If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease, etc).
NOTE:
The term 'life-threatening' in the definition of 'serious' refers to an event in which t... | [
"Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose:",
"a. Results in death",
"b. Is life-threatening",
"c. Requires hospitalization or prolongation of existing hospitalization NOTE:",
"d. Results in disability/incapacity",
"e. Is a congenital anomaly/birth defect"... |
NCT02531633 | 12.4.3 | Definition of Cardiovascular Events |
Investigators will be required to fill out the specific CV event page of the CRF for the following AEs and SAEs:
- Myocardial infarction/unstable angina
- Congestive heart failure
- Arrhythmias
- Valvulopathy
- Pulmonary hypertension
- Cerebrovascular events/stroke and transient ischemic attack
- Peripheral arteria... | [
"Cardiovascular Events (CV) Definition:"
] |
NCT02531633 | 12.4.4 | Recording of AEs and SAEs |
- When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation (e.g., hospital progress notes, laboratory, and diagnostics reports) relative to the event.
- The investigator will then record all relevant information regarding an AE/SAE in the CRF.
- It is not acceptable for the inve... | [
"AEs and SAE Recording:"
] |
NCT02531633 | 12.4.5 | Evaluating AEs and SAEs |
The investigator will make an assessment of intensity for each AE and SAE reported during the study and will assign it to one of the following categories:
Mild: An event that is easily tolerated by the subject, causing minimal discomfort
- and not interfering with everyday activities.
- Moderate: An event that is s... | [
"Assessment of Intensity",
"Assessment of Causality",
"Follow-up of AEs and SAEs"
] |
NCT02531633 | 12.4.6 | Reporting of SAEs to GSK |
- Primary mechanism for reporting SAEs to GSK will be the electronic data collection tool
- If the electronic system is unavailable for greater than 24 hours, the site will use the paper SAE data collection tool and fax it to the SAE coordinator.
- Site will enter the serious adverse event data into the electronic sy... | [
"SAE reporting to GSK via electronic data collection tool"
] |
NCT02531633 | 12.5 | Appendix 5: American College of Rheumatology Standard of Care Recommendations for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis\ | *
- Consider serial bone mineral density testing
- Consider annual serum 25-hydroxyvitamin D measurement
- Annual height measurement
- Assessment of incident fragility fracture
- Assessment of osteoporosis medication compliance
Pharmacologic Recommendations for Postmenopausal Women and Men age >50 Years Starting Gluc... | [
"Recommended Monitoring for Patients Receiving Prevalent Glucocorticoid Therapy for a Duration >3 Months",
"Low-risk patient",
"Medium-risk patient",
"High-risk patient"
] |
NCT02531633 | 12.6 | Appendix 6: Genetic Research |
The objectives of the genetic research are to investigate the relationship between genetic variants and:
- Response to medicine, including sirukumab, prednisone or any concomitant medicines;
- GCA susceptibility, severity, and progression and related conditions
Genetic data may be generated while the study is under... | [
"Genetic Research Objectives and Analyses",
"Study Population",
"Study Assessments and Procedures",
"Informed Consent",
"Subject Withdrawal from Study",
"Screen and Baseline Failures",
"Provision of Study Results and Confidentiality of Subject's Genetic Data"
] |
NCT02531633 | 12.7 | Appendix 7 - Country Specific Requirements | In Germany, subcutaneous administration of sirukumab or matching placebo must be discontinued for subjects with a clinically important, active infection. This treatment must be withheld until serious and/or severe infections have been completely resolved. This includes all opportunistic infections, sepsis or meningoenc... | [] |
NCT02531633 | 12.8 | Appendix 8: Exploratory US Imaging | The utility of US in monitoring disease activity in GCA will be investigated in a cohort of subjects with new onset GCA. Longitudinal changes in vascular inflammation of the temporal and axillary arteries will be characterized. Only subjects with new onset GCA will participate in order to optimize the ability to detect... | [] |
NCT02531633 | 12.8.1 | Objectives and Endpoints | The objectives and endpoints of this exploratory US imaging cohort are as follows:
| Objectives ... | [] |
NCT02531633 | 12.8.2 | Type and Number of Subjects | Only subjects with new onset GCA are eligible to participate in the exploratory imaging portion of this study. These subjects will have a diagnosis of GCA based on the Revised GCA Diagnosis Criteria, and present with new onset GCA disease, defined as having a diagnosis within 6 weeks of baseline. Subjects should have e... | [] |
NCT02531633 | 12.8.3 | Assessments and Procedures | [] | |
NCT02531633 | 12.8.3.1 | Sonographer Training | All sonographers participating in this study must have undergone training with documented approval to qualify as a participating site. Sites previously trained for participation in the TABUL study will not be required to participate in the training sessions, but may certify through a separate process. Processes and pro... | [] |
NCT02531633 | 12.8.3.2 | Subject Eligibility | Study subjects consenting to participate in the exploratory US imaging cohort are eligible only if they have newly diagnosed GCA (within 6 weeks of baseline), based on the Revised GCA Diagnosis Criteria as described in Section [5.1.](#page-36-0) At Baseline, subjects must have fulfilled all of the eligibility criteria ... | [] |
NCT02531633 | 12.8.3.3 | Ultrasound Scanning | Participating subjects will undergo US scans at the following time points:
- 1. Screening, or after consent has been provided to participate in the imaging cohort. Optimally (but not required), this scan would be performed within 3 days of initiating corticosteroid therapy for GCA disease activity:
- 2. Week 0 (Random... | [] |
NCT02531633 | 12.8.4 | Blinding | The central reader will remain blinded to the subject's treatment group. Investigators and sponsor will remain blinded to the central US results. No clinical findings will be communicated by the central reader to investigators. Scans may be reviewed at the site according to local policy. | [] |
NCT02531633 | 12.8.5 | Statistical Considerations and Data Analyses | [] | |
NCT02531633 | 12.8.5.1 | Hypotheses | The objectives of the evaluations in the US imaging cohort are exploratory and observational. There are no formal statistical hypotheses planned.
Exploratory comparisons will be made between the sirukumab and placebo arms, if appropriate. | [] |
NCT02531633 | 12.8.5.2 | Sample Size Considerations | There are no formal calculations of power or sample size for this cohort. There is no prespecified upper or lower limit for subject enrolment in this cohort. Therefore, no sample size sensitivity was performed and there are no plans for sample size re-estimation . | [] |
NCT02531633 | 12.8.5.3 | Data Analysis Considerations | No formal analyses are planned for this cohort. | [] |
NCT02531633 | 12.8.5.4 | Key Elements of Analysis Plan | Data from the US imaging cohort may be reported separately from the main 201677 clinical study report.
Data will be analyzed according to the timeframe between prednisone dose and US scan.
Graphics and/or descriptive statistics will be used to describe the time course and magnitude of changes in key markers (e.g. hal... | [] |
NCT02531633 | 12.9 | Appendix 9: Protocol Changes |
1. Clarification of the secondary objective and endpoint relating to characterization of disease remission. Characterization of disease flare over time has been delineated as a separate secondary objective.
Rationale: Sustained remission will be assessed at various time points throughout the 52-week treatment period... | [
"Amendment 01 15 October 2015",
"Investigators should carefully consider the individual benefit-risk of continuing sirukumab in those subjects that continue to experience flares or persistent disease activity following the start of open label treatment.",
"OR",
"Re-testing",
"criteria. An indeterminate resu... |
NCT02531633 | 12.8 | Appendix 8: Exploratory US Imaging | The utility of US in monitoring disease activity in GCA will be investigated in a cohort of subjects with new onset GCA. Longitudinal changes in vascular inflammation of the temporal and axillary arteries will be characterized. Only subjects with new onset GCA will participate in order to optimize the ability to detect... | [] |
NCT02531633 | 12.8.1 | Objectives and Endpoints | The objectives and endpoints of this exploratory US imaging cohort are as follows:
| Objectives | Endpoints ... | [] |
NCT02531633 | 12.8.2 | Type and Number of Subjects | Only subjects with new onset GCA are eligible to participate in the exploratory imaging portion of this study. These subjects will have a diagnosis of GCA based on the Revised GCA Diagnosis Criteria, and present with new onset GCA disease, defined as having a diagnosis within 6 weeks of baseline. Subjects should have e... | [] |
NCT02531633 | 12.8.3 | Assessments and Procedures | [] | |
NCT02531633 | 12.8.3.1 | Sonographer Training | All sonographers participating in this study must have undergone training with documented approval to qualify as a participating site. Sites previously trained for participation in the TABUL study will not be required to participate in the training sessions, but may certify through a separate process. Processes and pro... | [] |
NCT02531633 | 12.8.3.2 | Subject Eligibility | Study subjects consenting to participate in the exploratory US imaging cohort are eligible only if they have newly diagnosed GCA (within 6 weeks of baseline), based on the Revised GCA Diagnosis Criteria as described in Section 5.1. At Baseline, subjects must have fulfilled all of the eligibility criteria for Study 2016... | [] |
NCT02531633 | 12.8.3.3 | Ultrasound Scanning | Participating subjects will undergo US scans at the following time points:
- 1. Screening, or after consent has been provided to participate in the imaging cohort. Optimally (but not required), this scan would be performed within 3 days of initiating corticosteroid therapy for GCA disease activity:
- 2. Week 0 (Random... | [] |
NCT02531633 | 12.8.4 | Blinding | The central reader will remain blinded to the subject's treatment group. Investigators and sponsor will remain blinded to the central US results. No clinical findings will be communicated by the central reader to investigators. Scans may be reviewed at the site according to local policy. | [] |
NCT02531633 | 12.8.5 | Statistical Considerations and Data Analyses | [] | |
NCT02531633 | 12.8.5.1 | Hypotheses | The objectives of the US imaging cohort are exploratory and observational. There are no formal statistical hypotheses planned.
Exploratory comparisons will be made between the sirukumab and placebo arms, if appropriate. | [] |
NCT02531633 | 12.8.5.2 | Sample Size Considerations | There are no formal calculations of power or sample size for this cohort. There is no pre-specified upper or lower limit for subject enrolment in this cohort. Therefore, no sample size sensitivity was performed and there are no plans for sample size reestimation . | [] |
NCT02531633 | 12.8.5.3 | Data Analysis Considerations | No formal analyses are planned for this cohort. | [] |
NCT02531633 | 12.8.5.4 | Key Elements of Analysis Plan | Data from the US imaging cohort may be reported separately from the main 201677 clinical study report.
Data will be analyzed according to the timeframe between prednisone dose and US scan.
Graphics and/or descriptive statistics will be used to describe the time course and magnitude of changes in key markers (e.g. ha... | [
"Section 5.1 Inclusion Criteria #1",
"Section 5.1 Inclusion Criteria #2"
] |
NCT02531633 | 15 | Administrative changes | Updated author list, Table of Contents, name and contact information for GSK medical monitor and correction of typographical error in Abbreviations.
1. Clarification of the endpoints for the ultrasound imaging cohort.
Rationale: Occlusion and stenosis will not be assessed by sonographers. Since this is an exploratory... | [
"Amendment 03 17 November 2016",
"Three primary database locks (DBLs) are planned for reporting of the results:",
"All subjects and study site personnel will remain blinded to the treatment group assignment until all subjects of Part B have completed the Week 24 visit assessments of Part B.",
"The prednisone ... |
NCT02531633 | 23 | Current history of suicidal ideation or past history of suicide attempt. | 16. To clarify requirements for re-testing for ECG assessment and QuantiFERON-TB Gold test.
Section 5.3 Screening/Baseline/Run-in Failures
If a subject has signed the Informed Consent Form (ICF) and failed to meet at least one entry criterion, the site may retest laboratory values or repeat a study entry procedure on... | [
"Re-testing"
] |
NCT02531633 | 24 | Addition of the assessment of the C-SSRS | Rationale: Per GSK policy, prospective monitoring of suicidal ideation and behavior is implemented in clinical trials for investigational agents with potential activity on the central nervous system, including sirukumab.
Section 7: Study Assessments and Procedures
- 1. Patient Global Assessment of disease activity (P... | [
"9. Columbia-Suicide Severity Rating Scale (C-SSRS).",
"Injection Site Reactions",
"An overview of the multiplicity control is provided in Figure 2.",
"Rating Scale using interactive voice response technology. J Psychiat Res. 2010; 44(16):1224-1228."
] |
NCT02738359 | 1 | Descriptive analysis | The quantitative characteristics of the patients will be described in each group by the mean and the standard deviation, or by the quartiles and the minimum and maximum values according to the shape of the distribution. The qualitative characteristics of the patients will be described in each group by the absolute and ... | [] |
NCT02738359 | 2 | Non-inferiority analysis | The main analysis will be carried out in per protocol analysis. In this analysis, only the patients having received the assigned strategy will be considered. All patients with a major deviation to the protocol will be excluded. In the FIT group, the patients complying with at least one of the three screening rounds wil... | [] |
NCT02738359 | 3 | Analysis for secondary objectives | The efficacy of each strategy for the detection of advanced neoplasia will be estimated on the patients who will have actually received the strategy, whatever their initial randomization group. It will be estimated by the proportion of detected patients at 3 years. They will be estimated with a 95% confidence interval ... | [
"STUDY DURATION / CALENDAR",
"FEASIBILITY OF THE STUDY",
"Capacity of patients' inclusion",
"Network",
"SPECIFIC ROLE OF EACH PARTICIPATING TEAM",
"STUDY COORDINATION",
"EXPECTED CLINICAL VALUE OF THE PROJECT",
"ETHICS AND REGULATORY PROCESS",
"Risk-Benefit for patients",
"General Process",
"Saf... |
NCT02996682 | 1 | INTRODUCTION | [] | |
NCT02996682 | 1.1 | Background | Hepatitis C virus infection is a global health challenge with the estimated number of persons infected ranging from 80 to 150 million worldwide {Gower et al 2014, World Health Organization (WHO) 2016}. Hepatitis C virus has significant genetic (RNA sequence) variability and is classified on this basis into at least 6 g... | [] |
NCT02996682 | 1.1.1 | HCV Infection in Japan | With published HCV prevalence estimates from blood-donor and subgroup-based studies on the order of 1-1.9% in Japan {Sievert et al 2011}, it is estimated that there are approximately 1.3-2.4 million people chronically infected with HCV. The highest prevalence rates of HCV
antibodies in first-time blood donor studies h... | [] |
NCT02996682 | 1.2 | Sofosbuvir/Velpatasvir Fixed-Dose Combination | Sofosbuvir (SOF) is a nucleotide analog HCV NS5B polymerase inhibitor. Velpatasvir (VEL) is a pangenotypic HCV NS5A inhibitor. | [] |
NCT02996682 | 1.2.1 | General Information | Please refer to the Investigator's Brochure (IB) for additional information on SOF/VEL, and the individual components, including:
- InVitro Anti-Hepatitis C Virus Activity
- Nonclinical Pharmacokinetics and In Vitro Metabolism
- Nonclinical Pharmacology and Toxicology
- Clinical Experience | [] |
NCT02996682 | 1.3 | Information about Ribavirin | Ribavirin (RBV) is a guanosine analogue that inhibits the *in vitro* replication of a wide range of RNA and DNA viruses {MSD K.K. Kudan-kita Chiyoda-ku 2016}. RBV monotherapy has little or no effect on the replication of HCV *in vivo* but can result in normalization of serum ALT activity and improvement in liver histol... | [] |
NCT02996682 | 1.4 | Rationale for This Study | The GS-US-342-4019 study is a Phase 3 multicenter, open-label study evaluating SOF/VEL ± RBV for 12 weeks in subjects with HCV infection and Child-Pugh-Turcotte (CPT) class B or C cirrhosis. Approximately 100 subjects will be enrolled.
SOF/VEL with RBV for 12 weeks is approved in the US and EU (as Epclusa ® ) for the ... | [] |
NCT02996682 | 1.5 | Rationale for Dose Selection of SOF/VEL | Subjects in this study will be administered SOF/VEL, a co-formulation of SOF 400 mg and VEL 100 mg that is approved in the US, EU, and other regions as Epclusa® for the treatment of HCV infection in adults.
In the Phase 3 ASTRAL 1-3 studies, treatment of HCV infected subjects infected without cirrhosis or with compens... | [] |
NCT02996682 | 1.6 | Rationale for Dose Selection of Ribavirin | Data from the ASTRAL-4 and SOLAR studies support the use of different starting doses of RBV based on subject's CPT class at Screening so that subjects with CPT B cirrhosis will start at 600-1000 mg daily based on weight, whereas subjects with CPT C cirrhosis will start at 600 mg daily.
The SOLAR-1 and SOLAR -2 studies... | [] |
NCT02996682 | 1.7 | Risk/Benefit Assessment for the Study | This study will provide information of the safety and efficacy of the combination of SOF/VEL with or without RBV for 12 weeks in Japanese patients with decompensated cirrhosis.
The safety profile of SOF/VEL has been established in 3126 subjects, including 1558 subjects in the Phase 3 studies, 802 in the Phase 2 studie... | [] |
NCT02996682 | 1.8 | Compliance | This study will be conducted in accordance with ICH Good Clinical Practice (GCP), and J-GCP (Ministerial Ordinance on Good Clinical Practice for Drugs), and all applicable regulatory requirements, including archiving of essential documents. | [] |
NCT02996682 | 2 | OBJECTIVES | The primaty objectives of this study are:
- To evaluate the antiviral efficacy of therapy with sofosbuvir/velpatasvir (SOFNEL) fixed-dose combination (FDC) with or without ribavirin for 12 weeks as measured by the propotiion of subjects with sustained virologic response 12 weeks after cessation of fl·eatment (SVR12)
-... | [] |
NCT02996682 | 3 | STUDY DESIGN | [] | |
NCT02996682 | 3.1 | Study Design | This is a multicenter, randomized, open-label study evaluating the efficacy and safety of SOF/VEL ± RBV for 12 weeks in subjects with chronic HCV infection with decompensated cirrhosis.
Initially only subjects with CPT B cirrhosis at Screening (score 7-9) will be enrolled. Enrollment of subjects with CPT C cirrhosis a... | [] |
NCT02996682 | 3.2 | Study Treatments | Approximately 100 subjects will be randomized (1:1) to one of the following two treatment groups:
- SOF/VEL (400/100 mg) for 12 weeks (n=50)
- SOF/VEL (400/100 mg) with RBV for 12 weeks (n=50)
Randomization will be stratified by Child-Pugh-Turcotte (CPT) class at Screening (CPT B/ CPT C) and HCV genotype (genotype 1/... | [] |
NCT02996682 | 3.3 | Duration of Treatment | Subjects will be treated for 12 weeks.
The total time to complete all study visits is approximately 40 weeks (42 weeks for those requiring an extension of the Screening period):
- 28 days (4 weeks) screening period
- 12 weeks study treatment period
- 24 weeks posttreatment period | [] |
NCT02996682 | 3.4 | Stopping Rules and Discontinuation Criteria | If a subject discontinues study dosing (for example, as a result of an adverse event [AE]), every attempt should be made to keep the subject in the study and continue to perform the required
study-related follow-up procedures (see Section 6.5). If this is not possible or acceptable to the subject or investigator, the ... | [] |
NCT02996682 | 3.4.1 | Toxicity-Based Stopping Criteria | Subjects who meet any of the following laboratory or adverse event criteria must stop treatment with SOF/VEL:
- Confirmed total bilirubin > 3x Day 1 or nadir and ALT and/or AST > 3x Day 1 or nadir
- Elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 10x Day 1 or nadir, confirmed by i... | [] |
NCT02996682 | 3.4.2 | Virologic Response-Based Treatment Stopping Criteria | The following on-treatment Virologic Response-based Treatment Stopping Criteria will be utilized:
- Confi1med HCV RNA ~ LLOQ after 2 consecutive HCV RNA 1 log10 increase in HCV RNA from nadir
- HCV RNA~ LLOQ through 8 weeks of treatment
Confi1mation should be pe1f01med as soon as possible and must occur no later tha... | [] |
NCT02996682 | 4 | SUBJECT POPULATION | [] | |
NCT02996682 | 4.1 | Number of Subjects and Subject Selection | Approximately 100 chronic HCV infected, male and non-pregnant female subjects, ages 20 years or older with CPT class B or C cirrhosis at Screening will be enrolled in this study.
In order to manage the total study enrollment, Gilead Sciences, Inc., at its sole discretion, may suspend screening and/or enrollment at any... | [] |
NCT02996682 | 4.2 | Inclusion Criteria | Subjects must meet *all* of the following inclusion criteria to be eligible for participation in this study.
- 1) Willing and able to provide written informed consent
- 2) Male or female, age 20 years at Screening
- 3) Body weight ≥ 40 kg at Screening
- 4) Quantifiable HCV RNA at Screening
- 5) Chronic HCV infection (... | [] |
NCT02996682 | 4.3 | Exclusion Criteria | Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- 1) Current or prior history of any of the following:
- a) Clinically significant illness or currently under evaluation for a potentially clinically significant illness (other than HCV or co-morbidities associated with a... | [] |
NCT02996682 | 5 | INVESTIGATIONAL MEDICINAL PRODUCTS | [] | |
NCT02996682 | 5.1 | Randomization, Blinding and Treatment Codes | This is a multicenter, randomized, open-label study in subjects with chronic HCV infection with decompensated cirrhosis. No blinding is required.
Approximately 100 subjects will be randomized (1:1) to one of the following two groups:
- SOF/VEL (400/100 mg) for 12 weeks (n=50)
- SOF/VEL (400/100 mg) with RBV for 12 we... | [] |
NCT02996682 | 5.2 | Description and Handling of SOF/VEL FDC | [] | |
NCT02996682 | 5.2.1 | Formulation | The SOF/VEL (400/100 mg) tablets are pink, diamond-shaped, film-coated tablets, debossed with "GSI" on one side and "7916" on the other side. In addition to the active ingredients, the SOF/VEL tablets contain copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium ... | [] |
NCT02996682 | 5.2.2 | SOF/VEL FDC Packaging and Labeling | SOF/VEL (400/100 mg) tablets are packaged in white, high density polyethylene (HDPE) bottles. Each bottle contains 28 tablets and polyester packing material. Each bottle is enclosed with a white, continuous thread, child-resistant screw cap with an induction-sealed, aluminum-faced liner.
SOF/VEL bottles to be distribu... | [] |
NCT02996682 | 5.2.3 | SOF/VEL FDC Storage and Handling | SOF/VEL FDC tablets should be stored at controlled room temperature until required for administration. Controlled room temperature is defined as 25C (77 F); excursions are permitted between 15C and 30C (59F to 86F).
All drug products should be stored in a securely locked area, accessible only to authorized site person... | [] |
NCT02996682 | 5.2.4 | Dosage and Administration of SOF/VEL FDC | SOF/VEL tablet is to be administered once daily with or without food. Each subject must be given instructions to maintain approximately the same daily dosing interval between study drugs doses.
If a subject does not take the SOF/VEL FDC dose at the usual time, it may be taken up to 18 hours later; however, no more tha... | [] |
NCT02996682 | 5.3 | Description and Handling of Ribavirin (RBV) | [] | |
NCT02996682 | 5.3.1 | Formulation | RBV will be provided in the course of this study as REBETOL capsules (MSD K.K.). REBETOL capsules are white opaque hard capsules. Each capsule contains 200 mg of ribavirin. Information regarding commercially available REBETOL capsules can be found in the current prescribing information {MSD K.K. Kudan-kita Chiyoda-ku 2... | [] |
NCT02996682 | 5.3.2 | RBV Packaging and Labeling | REBETOL capsules are packaged in blister packaging of 140 capsules. The RBV package shall be labeled for clinical use to meet all applicable requirements of the J-GCP (Ministerial Ordinance on Good Clinical Practice for Drugs). | [] |
NCT02996682 | 5.3.3 | RBV Storage and Handling | Information regarding commercially available REBETOL capsules can be found in the current prescribing information.
All drug products should be stored in a securely locked area, accessible only to authorized site personnel. To ensure the stability of the study drug and to ensure proper product identification, the drug ... | [] |
NCT02996682 | 5.3.4 | Dosage and Administration of RBV | For subjects with CPT B cirrhosis at Screening, RBV dosage will be based on weight. Subjects with CPT C cirrhosis at Screening will be administered 600 mg in a divided daily dose. See Table 5-1 below.
Table 5-1. Dosing and Administration of RBV
| CPT Class | Body Weight atDay 1 | Daily dosage | After morningmeal | A... | [] |
NCT02996682 | 5.4 | Co-administration of SOF/VEL and RBV | For morning doses, subjects will be instructed to take study drugs with food as follows:
- One SOF/VEL FDC Tablet: contains 400 mg of SOF and 100 mg of VEL
- RBV as per Table 5-1
For evening doses, subjects will be instructed to take study drug with food as follows:
If a subject does not take the SOF/VEL dose at the... | [
"RBV as per Table 5-1"
] |
NCT02996682 | 5.5 | Study Drug Adherence and Drug Accountability | Subjects must be instructed to bring back all study drug(s) in the original container at every study visit after Day 1 through the end of treatment.
Study drug(s) will be reconciled using medication pill count at every post-Day 1 visit by the investigator or designee (ie, pharmacist) in order to monitor the subject's ... | [] |
NCT02996682 | 5.6 | Prior and Concomitant Medications | All concomitant medications taken within 30 days prior to Screening, up to and including 30 days after the last dose of study drug, need to be recorded in the source documents and eCRF (including all blood products). In addition, records of concomitant medications for ascites and hepatic encephalopathy taken through po... | [
"Colony Stimulating Agents"
] |
NCT02996682 | 5.7 | Accountability for Study Drug | The investigator or designee (ie, pharmacist) is responsible for ensuring adequate accountability of all used and unused study drugs. This includes acknowledgement of receipt of each shipment of study drugs (quantity and condition). All used and unused study drugs dispensed to subjects must be returned to the site.
SO... | [] |
NCT02996682 | 5.7.1 | Study Drug Return or Disposal | Refer to Section 9.1.7 for information on return and disposal of study drugs. | [] |
NCT02996682 | 6 | STUDY PROCEDURES | The study procedures to be conducted for each subject emolled in the study are presented in tabula!' fonn in Appendix 2 and described in the text that follows
The investigator must docmnent any deviation from protocol procedures and notify the sponsor or contract research organization (CRO). | [] |
NCT02996682 | 6.1 | Screening Visit | Screening assessments will be completed within 28 days of the Day 1 visit. The screening window can be extended up to 42 days for subjects for extenuating circmnstances with sponsor approval. A single retest of screening labs is permitted only if there is reason to believe the retest value will be within accepted param... | [] |
NCT02996682 | 6.1.1 | Day 1 Assessments | The following Day 1 tests and procedures must be performed prior to enrollment and dosing/dispensation of study drugs:
- Determine inclusion and exclusion eligibility (refer to Sections 4.1 and 4.2)
- Confirm CPT score is 7-12 using laboratory data from the local laboratory (refer to Section 6.8.7)
- Subject complet... | [] |
NCT02996682 | 6.2 | Study Drug Administration | An Interactive Web Response System (IWRS) will be employed to manage subject enrollment, randomization, and treatment assignment. Randomization stratification factors are described in Section 5.1.
When ready to administer study drugs to the subject:
- Dispense study drugs as directed by the IWRS
- Instruct the subjec... | [] |
NCT02996682 | 6.3 | Close Monitoring During Early Phase of Treatment for Subjects with CPT C Cirrhosis | Subjects with CPT C cirrhosis at Screening should be monitored closely during treatment with SOF/VEL ± RBV. The extent and duration of monitoring is at the discretion of the Investigator, based on assessment of each individual subject, but may include daily contact with subject (or subject's family) or in-patient hospi... | [] |
NCT02996682 | 6.4 | Treatment Assessments (± 3 days) | On-treatment visits will be performed at the end of Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 for all subjects.
Study drugs will be reconciled at every post-Day 1 visit by the investigator or designee (ie pharmacist) in order to monitor the subject's adherence with the study drugs. | [] |
NCT02996682 | 6.4.1 | Weeks 1, 3, 5, 6, 7, 9, 10, and 11 (± 3 days) | The following procedures/assessments are to be completed at the end of Weeks 1, 3, 5, 6, 7, 9, 10, and 11:
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs (refer to Section 6.8.4)
- Assessment of AEs and concomitant medications
- Assess adherence with study drug do... | [] |
NCT02996682 | 6.4.2 | Week 2 (± 3 days) | The following procedures/assessments are to be completed at the end of Week 2:
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs (refer to Section 6.8.4)
- Assessment of AEs and concomitant medications
- Assess adherence with study drug dosing regimen including pill ... | [] |
NCT02996682 | 6.4.3 | Weeks 4 and 8 (± 3 days) | The following procedures/assessments are to be completed at the end of Weeks 4 and 8:
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs (refer to Section 6.8.4)
- Assessment of AEs and concomitant medications
- Assess presence and severity of ascites and hepatic ence... | [] |
NCT02996682 | 6.4.4 | Week 12 (± 3 days) | The following procedures/assessments are to be completed at the end of Week 12:
- Subject completes Health Related Quality of Life (HRQoL) surveys (refer to Section 6.8.6)
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs (refer to Section 6.8.4)
- Assessment of AEs ... | [] |
NCT02996682 | 6.5 | Posttreatment Assessments (± 5 days) | The posttreatment Week 4, 12, and 24 visits should be timed from the date of last administration of any study drugs for all subjects, regardless of whether they are a virologic failure or discontinued study drugs early. | [] |
NCT02996682 | 6.5.1 | Posttreatment Week 4 (± 5 days) | The following procedures/assessments are to be completed for all subjects, 4 weeks after taking the last dose of study drug:
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs (refer to Section 6.8.4)
- Assessment of AEs and concomitant medications
- Assess presence a... | [] |
NCT02996682 | 6.5.2 | Posttreatment Week 12 (± 5 days) | The following procedures/assessments are to be completed for all subjects, 12 weeks after taking the last dose of study drug:
- Subject completes Health Related Quality of Life (HRQoL) surveys (refer to Section 6.8.6)
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs... | [] |
NCT02996682 | 6.5.3 | Posttreatment Week 24 (± 5 days) | The following procedures/assessments are to be completed for all subjects, 24 weeks after taking the last dose of study drug:
- Perform complete physical examination (refer to Section 6.8.3)
- Obtain weight
- Obtain vital signs (refer to Section 6.8.4)
- Assess presence and severity of ascites and hepatic encephalopat... | [] |
NCT02996682 | 6.6 | Early Termination (ET) | For subjects who have completed an ET visit, the posttreatment Week 4, 12, and 24 follow-up visits will be scheduled after the last dose of the study drugs.
When medically feasible, the medical monitor must be consulted prior to subject discontinuation.
The following procedures/assessments are to be completed at an E... | [] |
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