SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
Status: | Active, not recruiting |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2013 |
End Date: | June 2016 |
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.
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+peginterferon alfa-2a
(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.
sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a
(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.
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.
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.
We found this trial at
24
sites
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