PH III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Inelgibles. Naives)

• Conditions: HEPATITIS C VIRUS; 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: EUCTR2011-005446-35-IE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-14
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified