(New England IRB) A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects with Genotype 1 Chronic Hepatitis C [Protocol: AI443102]

Trial ID:
IRB-13-6271
Paul Pockros
To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
  • Treatment-experienced subjects are eligible

Exclusion Criteria:

  • Evidence of cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to enrollment
  • Documented or suspected HCC
  • Evidence of decompensated liver