A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Treatment Naïve and Treatment Experienced Subjects with Chronic Genotype 2 or 3 HCV Infection.
- Conditions
- liver diseaseliver inflammation1001965410047438
- Registration Number
- NL-OMON39204
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Subjects must meet the following eligibility criteria:
• Age >= 18 with chronic genotype 2 or 3 HCV infection
• HCV RNA >= 104 IU/mL at Screening
• Classification as treatment naïve or treatment experienced
Treatment naïve is defined as having never received treatment for
HCV with interferon (IFN).
Treatment experienced is defined as either
* IFN intolerant: Subject had documented intolerance to
IFN during prior IFN therapy of <=12 weeks duration. OR
* Treatment failure: Subject has documented prior treatment failure with >= 12 weeks IFN with or without RBV. Permissible IFNs include IFN alfa-2a (Roferon-A®), pegIFN alfa-2a (Pegasys®), IFN alfa-2b (Intron A®), pegIFN alfa-2b (PegIntron®), IFN alfacon-1 (Infergen®). The subject*s medical records must include sufficient detail of prior treatment with IFN (start/stop dates and viral response) to allow for categorization of prior response as either:
• Non-Response: Subject did not achieve undetectable HCV RNA levels on treatment.
• Relapse/Breakthrough: Subject achieved undetectable HCV RNA during treatment or within 4 weeks after treatment.
• Cirrhosis determination
• Cirrhosis is defined as any one of the following:
* Liver biopsy showing cirrhosis
* Fiboscan (in countries where locally approved) showing cirrhosis or results > 12.5 kPa
* FibroTest® score of >0.75 AND an AST:platelet ratio index (APRI) of >2 during Screening
• Absence of cirrhosis is defined as any one of the following:
* Liver biopsy within 2 years of Screening showing absence of cirrhosis
* Fibroscan (in countries where locally approved) with a result of <= 12.5 kPa within <= 6 months of
Baseline/Day1
* FibroTest® score of <= 0.48 AND APRI of <= 1 during Screening
In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or
FibroTest®
• Body mass index (BMI) >= 18 kg/m2
• Screening laboratory tests within specified parameters
• Agree to use two forms of highly effective contraception for the duration of the study and for 6 months after the last dose of study medication. Females of childbearing potential must have
a negative pregnancy test at Screening and Baseline/Day 1
Subjects will be ineligible if they meet any of the following exclusion criteria:
• Prior exposure to a direct-acting antiviral targeting the HCV NS5B polymerase.
• History of any other clinically significant chronic liver disease (e.g., hemochromatosis, Wilson*s disease)
• Evidence of or history of decompensated liver disease
• HIV or chronic hepatitis B virus (HBV) infection
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• Chronic use of systemic immunosuppressive agents or immunomodulatory agents
• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject*s
participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study hypothesis is that GS-7977+RBV administered for 12 weeks will be<br /><br>superior to placebo. The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12<br /><br>weeks after cessation of therapy).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy endpoints include the proportion of subjects with HCV RNA <<br /><br>LLOQ at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24); viral<br /><br>breakthrough; and relapse.<br /><br><br /><br>Safety endpoint: The primary safety endpoint is any AE leading to permanent<br /><br>discontinuation of study drug(s).<br /><br><br /><br>other endpoint of interest: Additional efficacy evaluations may include HCV RNA<br /><br>change from Baseline/Day 1; ALT normalization; and viral kinetic parameters.</p><br>