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

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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.


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
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New Orleans, LA
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Arlington, TX
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Boston, MA
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Hillsborough, NJ
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Miami, FL
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Nashville, TN
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Novi, MI
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St. Paul, MN
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Wellington, FL
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