A Study of an investigational treatment regimen of daclatasvir (DCV) + asunaprevir (ASV) + BMS-791325 in a fixed dose combination (the triple regimen) with or without ribavirin (RBV) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in subjects with compensated cirrhosis

Phase 1

• Conditions: HEPATITIS C VIRUS; MedDRA version: 18.0Level: LLTClassification code 10072848Term: Hepatitis C virus genotype 1 positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-002458-66-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-11-26
• Study Start: 2015-06-19
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Key Inclusion Criteria:
• Subjects chronically infected with HCV genotype 1
• Subjects with compensated cirrhosis;
• HCV RNA = 10,000 IU/mL at screening;
• Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNa, pegIFNa), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
• Treatment-experienced subjects are eligible including exposure to anti-HCV agents of a mechanistic class other than those contained in the DCV/ASV/BMS-791325 triple regimen is permitted. Examples of permitted agents include, but are not limited to nucleoside/nucleotide inhibitors of NS5B polymerase, inhibitors of cyclophilin, or inhibitors of
microRNA.
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 282
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

Key Exclusion Criteria:
• Subjects without cirrhosis
• Liver or any other organ transplant
• Current or known history of cancer within 5 years prior to screening;
• Documented or suspected HCC,;
• Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Study & Design

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