NCT01193361: HEPCAT

A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

Completed Phase 2 Last updated 23 September 2015

What this trial tests

Phase 2 trial testing BMS-791325 in Hepatitis C Virus in 39 participants. Completed in 1 November 2012.

Timeline

1 October 2010

Primary endpoint
1 June 2011

1 November 2012

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	39
Start date	1 October 2010
Primary completion	1 June 2011
Estimated completion	1 November 2012
Sites	10 locations across United States

Drugs / interventions tested

• BMS-791325 — full drug profile →
• BMS-791325 — full drug profile →
• Placebo
• Peg-interferon alfa-2a
• Ribavirin — full drug profile →

Conditions studied

• Hepatitis C Virus — all drugs for Hepatitis C Virus →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 70, any sex, with Hepatitis C Virus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
  Time frame: Formal analysis at week 4 (and upon occurrence)
• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
  Time frame: Formal analysis at week 12 (and upon occurrence)
• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
  Time frame: Formal analysis at week 24 post treatment (and upon occurrence)
• Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
  Time frame: Formal analysis at week 48 post treatment (and upon occurrence)
• Antiviral activity, as determined by the proportion subjects with eRVR
  Time frame: Week 4
• Antiviral activity, as determined by the proportion subjects with eRVR
  Time frame: Week 12

Sponsor's own description

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection.
   Sims KD, Lemm J, Eley T, Liu M, et al · · 2014 · cited 25× · PMID 24733462 · DOI 10.1128/aac.02579-13