Study evaluating Asunaprevir and Daclatasvir in combination with Pegasys and Copegus, in Genotype 1 and 4 Subjects with Chronic Hepatitis C who do not adequately respond to Peginterferon Alfa 2a or 2b plus Ribavirin.
- Conditions
- Chronic Hepatitis C Virus Infection (Genotypes 1 and 4)MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005422-21-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 496
? Males and females, ? 18 years of age;
? HCV Genotype 1 or 4 who previously failed treatment with P/R, classified as previous null and partial responders based on previous therapy;
? HCV RNA ? 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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
? 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;
? Total bilirubin ? 34 ?mol/L (or ? 2 mg/dL) unless subject has a documented history of Gilbert?s disease;
? Confirmed ALT ? 5x ULN;
? Confirmed Albumin < 3.5 g/dL (35 g/L)
? AFP > 100 ng/mL OR ? 50 and ? 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of HCC are excluded;
? ANC < 1.5 x 10 billion cells/L (< 1.2 x 10 billion cells/L for Black/African-Americans);
? Confirmed Platelets < 90 x 10 billion cells/L;
? Hemoglobin < 12 g/dL for females or < 13 g/dL for males;
? Any criteria that would exclude the subject from receiving P/R.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method