EUCTR2011-005446-35-GB
Active, not recruiting
Phase 1
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 Revised Protocol Number 03, Incorporates amendment 04 dated 14-Jun-2013 - Hallmark DUA
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HEPATITIS C VIRUS
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 975
- Status
- Active, not recruiting
- Last Updated
- 6 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).
- •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 990
- •F.1\.3 Elderly (\>\=65 years) yes
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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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)Hepatitis CChronic Hepatitis C infection or Chronic HCV10047438NL-OMON37621Bristol-Myers Squibb18
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