A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection.;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12)
- Conditions
- Hepatitis CChronic Hepatitis C infection or Chronic HCV10047438
- Registration Number
- NL-OMON37621
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
* Males and females, * 18 years of age;;* HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with cirrhosis, OR treatment naive;;* HCV RNA * 104 IU/mL (10,000 IU/mL);;* Seronegative for HIV and HBsAg;;* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population).
* Prior treatment of HCV with HCV direct acting antiviral (DAA); ;* Evidence of a medical condition contributing to chronic liver disease other than HCV;;* Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;;* Diagnosed or suspected hepatocellular carcinoma or other malignancies;;* Uncontrolled diabetes or hypertension;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>Proportion of treated subjects with SVR-12, defined as HCV RNA < LOQ at post<br /><br>treatment Week 12, for subjects who are prior null or partial responders to P/R<br /><br>or are treatment-naive.</p><br>
- Secondary Outcome Measures
Name Time Method