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: 16.0Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005422-21-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-20
• Last Update Posted: 19 May 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:
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;
• ALT = 5x ULN;
• Albumin < 3.5 g/dL (35 g/L)
• AFP > 100 ng/mL (> 82.6 IU/mL) OR = 50 and = 100 ng/mL (= 41.3 IU/mL and = 82.6 IU/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