Chronic Hepatitis C Virus Infection MedDRA version: 18.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: Sofosbuvir/Velpatasvir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SOFOSBUVIR
CAS Number: 1190307-88-0
Current Sponsor code: GS-7977
Other descriptive name: SOFOSBUVIR
C
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 = 18 years. 3) HCV RNA = to 104 IU/mL at Screening. 4) HCV genotype 1, 2, 3, 4, 5, 6 assessed at Screening by the Central Laboratory. 5) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy. 6) Classification as treatment naïve or treatment experienced. 10) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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 (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 2) Screening ECG with clinically significant abnormalities 3) Any of the following laboratory parameters at screening: a) ALT > 10 x the upper limit of normal (ULN) b) AST > 10 x ULN c) Direct bilirubin > 1.5 x ULN d) Platelets 8.5% f) Creatinine clearance (CLcr) 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 4) Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of treatment with SOF/VEL fixed dose combination (FDC) for 12 weeks in subjects with chronic HCV infection as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR12) - To evaluate the safety and tolerability of treatment with SOF/VEL for 12 weeks;Secondary Objective: - To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) - To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment - To evaluate the emergence of viral resistance to SOF and VEL during treatment and after cessation of treatment;Primary end point(s): The primary endpoints of this study are: - Primary efficacy endpoint is SVR12 in all enrolled subjects after 12 weeks of SOF/VEL treatment - Primary safety endpoint is Safety and tolerability after 12 weeks of SOF/VEL treatment and AE leading to drug discontinuation;Timepoint(s) of evaluation of this end point: The safety and tolerability endpoints are evaluated during the course of treatment. The efficacy endpoint is evaluated 12 weeks after discontinuation of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints of this study are: - SVR4 and SVR24 in all enrolled subjects after 12 weeks of SOF/VEL treatment - Kinetics of HCV virus - Emergence of the viral resistance after 12 weeks of treatment and resistance associated variants;Timepoint(s) of evaluation of this end point: The efficacy endpoints are evaluated 4 and 24 weeks after discontinuation of therapy. The other endpoints are evaluated during the course of treatment. | — |
Countries
Russian Federation, Sweden
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed