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 infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005422-21-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-12
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

• 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: 0
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

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; • Total bilirubin = 34 µmol/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