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
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Willing and able to provide written informed consent 2) Male or female, age =18 years 3) Body mass index (BMI) = 18 kg/m2 4) HCV RNA = 104 IU/mL at Screening 5) Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy. 6) Treatment experienced with an NS5A inhibitor-containing regimen of at least a 4-week duration. 7) Cirrhosis Determination a) Presence of cirrhosis is defined as in the protocol b) Absence of cirrhosis is defined as in the protocol 8) Liver imaging within 6 months prior to Day 1 is required in cirrhotic subjects to exclude hepatocellular carcinoma (HCC) 9) Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 prior to enrollment 10) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 11) Lactating females must agree to discontinue nursing before starting study drug. 12) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator 13) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments 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 342 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: 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; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded b. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy d. Hepatic decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage) e. Solid organ transplantation f. Significant cardiac disease g. Unstable psychiatric condition including hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening h. Malignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection. i. Significant drug allergy (e.g., hepatotoxicity) 2) Screening ECG with clinically significant abnormalities 4) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis) 5) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 6) Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator 7) Use of any prohibited concomitant medications 8) Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 proportion of subjects with virologic failure To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment To evaluate the emergence of viral resistance to SOF, VEL, and GS-9857 during treatment and after cessation of treatment To characterize steady state pharmacokinetics of the study drug To further evaluate efficacy and safety of SOF/VEL/GS-9857 for 12 weeks in subjects who enter the Deferred Treatment Substudy;Main Objective: To determine the efficacy of treatment with sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 fixed dose combination (FDC) for 12 weeks 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/GS-9857;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of treatment) in the Full Analysis Set (FAS) in Group 1. The primary safety endpoint is any AE that led to permanent discontinuation of study drug.;Timepoint(s) of evaluation of this end point: 12 weeks post last treatment dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include the following: - The proportion of subjects with HCV RNA < LLOQ at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24) - The proportion of subjects with HCV RNA < LLOQ on treatment - HCV RNA change from Baseline/Day 1 - The proportion of subjects with virologic failure;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be assessed on treatment or 4 or 24 weeks following discontinuation of treatment | — |
Countries
Australia, Canada, France, Germany, New Zealand, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed