NL-OMON37621CompletedPhase 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
Bristol-Myers Squibb0 sites18 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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;
Investigators
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