EUCTR2011-005446-35-ITActive, not recruitingNot Applicable
A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null orPartial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant orIneligible to P/R Subjects and Treatment-Naive Subjects with ChronicHepatitis C Genotype 1b Infection - Hallmark DUA
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 sites1,100 target enrollmentStarted: September 3, 2012Last updated:
Conditions
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
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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 990
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
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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