Chronic Hepatitis C virus infection MedDRA version: 19.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: SOF/VEL/VOX
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sofosbuvir
CAS Number: 1190307-88-0
Current Sponsor code: GS-7977
Concentration unit: mg milligram(s)
Concentrati
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) HCV RNA = LLOQ at Screening 4) Received SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks in GS-US-367-1172 (POLARIS-2), GS-US-367-1173 (POLARIS-3), or GS-US-367-1170 (POLARIS-4), or received HCV treatment with a DAA-based regimen in another Gilead-sponsored study, with approval from Gilead Sciences prior to Screening 5) Cirrhosis Determination 6) Liver imaging within 6 months prior to Day 1 is required in cirrhotic subjects to exclude hepatocellular carcinoma (HCC) 7) 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 8) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 9) Lactating females must agree to discontinue nursing before starting study drug 10) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator 11) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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. Subjects under evaluation for possible malignancy are not eligible. i. Significant drug allergy (e.g., hepatotoxicity) 2) Screening ECG with clinically significant abnormalities 3) Subjects with laboratory parameters at screening as defined in the protocol 4) Prior treatment with SOF/VEL/VOX±RBV for =12 weeks 5) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis) 6) Infection with human immunodeficiency virus (HIV) 7) Hepatitis B surface antigen positive (HBsAg+) at Screening 8) 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 9) Use of any prohibited concomitant medications 10) Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of treatment with SOF/VEL/VOX 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/VOX FDC;Secondary Objective: To determine the proportion of subjects who attain SVR at 4 weeks after cessation of treatment (SVR4) 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 VOX during treatment and after cessation of treatment;Primary end point(s): The primary efficacy endpoint is SVR12 in the Full Analysis Set (FAS) population. The primary safety endpoint is any AE leading 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: - SVR4 - The proportion of subjects with HCV RNA < LLOQ on treatment - The proportion of subjects with virologic failure - HCV RNA change from Baseline/Day 1;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints will be assessed on treatment and 4 and 12 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