NL-OMON37621
Completed
Phase 3
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) - Hallmark DUA
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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).
Exclusion Criteria
- •\* 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;
Outcomes
Primary Outcomes
Not specified
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