EUCTR2011-005446-35-ESActive, not recruitingNot Applicable
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-2012) - Hallmark DUA
Bristol-Myers Squibb International Corporation0 sites1,100 target enrollmentStarted: May 29, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 1,100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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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