A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.
SOF
+ RBV
+ Peg-IFN
Blood-Borne Infections+8
+ Communicable Diseases
+ Digestive System Diseases
Treatment Study
Summary
Study start date: September 24, 2013
Actual date on which the first participant was enrolled.This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.601 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Key Inclusion Criteria: * Male or female, age greater than or equal to 18 years. * Confirmed chronic HCV infection. * Subjects will have cirrhosis status assessment; liver biopsy may be required. * Genotype 2 subjects must have cirrhosis of the liver to be eligible. * Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event * Infection with HCV genotype 2 or 3 as determined at Screening * Body mass index (BMI) greater than or equal to 18 kg/m\^2 * Screening laboratory values within predefined thresholds. * Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC. * Subject must be of generally good health as determined by the Investigator. Key Exclusion Criteria: * Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase * Pregnant or nursing female or male with pregnant female partner * History of any other clinically significant chronic liver disease. * HIV or chronic hepatitis B virus (HBV) infection. * Malignancy with the exception of certain resolved skin cancers. * Chronic use of systemically administered immunosuppressive agents. * Clinically-relevant drug or alcohol abuse. * History of solid organ transplantation. * Current or prior history of clinical hepatic decompensation. * History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. * Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives