Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221455

Enrollment

189

Registered

2011-05-10

Start date

2011-05-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Interventions

investigational material(s) Generic name etc : Pegylated Interferon Lambda, BMS-790052,Ribavirin,BMS-650032,Pegylated Interferon Alfa-2a,Placebo for BMS-650032,Placebo for BMS-790052,Placebo for Ribav

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic Hepatitis C, Genotype 1 HCV RNA >100,000 IU/mL at screening; Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg); Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion criteria

Exclusion criteria: Any evidence of liver disease other than HCV; Co-infection with HIV; Diagnosed or suspected hepatocellular carcinoma; Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Design outcomes

Primary

Measure	Time frame
Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs) Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with sustained virologic response (SVR)	—

Secondary

Measure	Time frame
Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) Proportion of subjects with either a 2-log or greater decrease in HCV RNA levels from baseline or undetectable levels of HCV RNA at Weeks 2, 4 and 12 Proportion of subjects with viral breakthrough Serum HCV Ribonucleic acid (RNA) levels over time	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026