Chronic Genotype 2 or 3 HCV Infection MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: GS-7977
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)
Concentration t
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. Confirmation of chronic HCV infection 4. Classification as treatment naïve or treatment experienced 5. Cirrhosis determination (approximately 20% of subjects may have cirrhosis) 6. Liver imaging within 6 months of Baseline/Day 1 (required in cirrhotic patients only, to exclude hepatocellular carcinoma) 7. Infection with HCV genotype 2 or 3 as determined at Screening 8. HCV RNA = 10e4 IU/mL at Screening 9. Body mass index (BMI) = 18 kg/m2 10. Screening ECG without clinically significant abnormalities 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 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Prior exposure to a direct-acting antiviral targeting the HCV NS5B polymerase 2. Pregnant or nursing female or male with pregnant female partner 3. Chronic liver disease of a non-HCV etiology 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 5. Contraindication to RBV therapy 6. History of malignancy diagnosed or treated within 5 years; subjects under evaluation for malignancy are not eligible 7. History of clinically significant hemoglobinopathy 8. Chronic use of systemically administered immunosuppressive agents 9. Clinically-relevant drug or alcohol abuse within 12 months of screening. 10. History of solid organ transplantation 11. Current or prior history of clinical hepatic decompensation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: • To determine the efficacy of treatment with GS-7977+ ribavirin (RBV) as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12) • To assess the safety and tolerability of GS-7977+RBV as measured by review of the accumulated safety data;Secondary Objective: The secondary objectives of this study are: • To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) • To determine the efficacy of treatment with GS-7977+RBV based on prior treatment history • To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation • To evaluate the emergence of viral resistance to GS-7977 during treatment and after treatment discontinuation;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12 weeks after cessation of therapy).;Timepoint(s) of evaluation of this end point: 12 weeks after cessation of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints include the proportion of subjects with HCV RNA < LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24); viral breakthrough; and relapse.;Timepoint(s) of evaluation of this end point: 4 and 24 weeks after cessation of therapy. | — |
Countries
Austria, Estonia, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom
Contacts
Public ContactMedical Monitor
Gilead Sciences Inc.
Outcome results
None listed