Phase 2 Safety Study of Pegylated Interferon Lambda plus single or 2 Direct Antiviral Agents with Ribarvirin

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 Revised Protocol Number: 02 Incorporates Administrative Letter 01, Amendment(s) 03 and 06 - The D-LITE Study: Direct Antiviral Agents plus Lambda Interferon Treatment Evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022568-11-DE

Enrollment

200

Registered

2011-01-31

Start date

2011-04-20

Completion date

Unknown

Last updated

2015-09-14

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

Conditions

Chronic Hepatitis C MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: Pegylated Interferon Lambda Product Code: BMS-914143 / PEG-rIL-29 / PEG IFN-?1 Pharmaceutical Form: Solution for injection INN or Proposed INN: PEGYLATED INTERFERON LAMBDA CAS Number: 91

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Chronic Hepatitis C, Genotype 1 •HCV RNA >100,000 IU/mL at screening; •Seronegative for HIV and HBsAg; •Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10% 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

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
Main Objective: • Part A: To evaluate the safety and tolerability (as measured by the frequency of SAEs, dose reductions and discontinuations due to AEs) through end of treatment (maximum of 48 weeks) plus 30 days of pegIFN? administered with RBV + a single direct antiviral agent (DAA) (BMS-790052 or BMS-650032) • Part B: To evaluate the safety and tolerability (as measured by the frequency of SAEs, dose reductions and discontinuations due to AEs) through end of treatment (maximum of 48 weeks) plus 30 days of pegIFN? administered with or without RBV + 2 DAA (BMS-790052 and BMS-650032) • To describe the antiviral activity as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) for Part A and Part B;Secondary Objective: • To describe the antiviral activity as determined by the proportion of HCV genotype 1 subjects with PDR for Part A or Part B • To assess serum HCV RNA levels, as measured by the Roche COBAS Taqman test version 2 • To describe the antiviral activity as determined by the proportion of HCV genotype 1 subjects with SVR4 and the proportion with SVR12 for Part A and Part B • To investigate the relationship between pegIFN? and BMS-650032 or BMS-790052 exposure and antiviral responses • To describe DAA-resistant variants associated with virologic failure + Exploratory Objectives: • To investigate the effect on patient reported outcomes (PROs) of repeat dosing with pegIFN? in combination with DAAs ± RBV • To investigate the relationship between PD biomarkers and clinical responses to pegIFN? • To investigate the association of host genetic factors with clinical responses to treatment with pegIFN? • To evaluate the immunogenicity of pegIFN?;Primary end point(s): Primary Assessments (Parts A and B): 1) Safety: Frequency of SAEs, dose reductions and discontinuations due to AEs through end of treatment (maximum of 48 weeks) plus 30 days 2) Efficacy: Proportion of HCV genotype 1 subjects with 24-week sustained v	—

Measure

Time frame

Main Objective: • Part A: To evaluate the safety and tolerability (as measured by the frequency of SAEs, dose reductions and discontinuations due to AEs) through end of treatment (maximum of 48 weeks) plus 30 days of pegIFN? administered with RBV + a single direct antiviral agent (DAA) (BMS-790052 or BMS-650032) • Part B: To evaluate the safety and tolerability (as measured by the frequency of SAEs, dose reductions and discontinuations due to AEs) through end of treatment (maximum of 48 weeks) plus 30 days of pegIFN? administered with or without RBV + 2 DAA (BMS-790052 and BMS-650032) • To describe the antiviral activity as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) for Part A and Part B;Secondary Objective: • To describe the antiviral activity as determined by the proportion of HCV genotype 1 subjects with PDR for Part A or Part B • To assess serum HCV RNA levels, as measured by the Roche COBAS Taqman test version 2 • To describe the antiviral activity as determined by the proportion of HCV genotype 1 subjects with SVR4 and the proportion with SVR12 for Part A and Part B • To investigate the relationship between pegIFN? and BMS-650032 or BMS-790052 exposure and antiviral responses • To describe DAA-resistant variants associated with virologic failure + Exploratory Objectives: • To investigate the effect on patient reported outcomes (PROs) of repeat dosing with pegIFN? in combination with DAAs ± RBV • To investigate the relationship between PD biomarkers and clinical responses to pegIFN? • To investigate the association of host genetic factors with clinical responses to treatment with pegIFN? • To evaluate the immunogenicity of pegIFN?;Primary end point(s): Primary Assessments (Parts A and B): 1) Safety: Frequency of SAEs, dose reductions and discontinuations due to AEs through end of treatment (maximum of 48 weeks) plus 30 days 2) Efficacy: Proportion of HCV genotype 1 subjects with 24-week sustained v

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary Assessments (Parts A and B): 1) Proportion of HCV genotype 1 subjects with PDR. Part A PDR is defined as HCV RNA at Week 4 1 log(10) increase in HCV RNA over nadir or confirmed HCV RNA = LLOQ after confirmed undetectable HCV RNA while on treatment; 9) Proportion of subjects with undetectable relapse, defined as HCV RNA at the end of treatment followed bydetectable levels of HCV RNA in any follow-up visit window. Detectable measurements should be confirmed with 2 weeks of receipt of the initial HCV RNA result.;Timepoint(s) of evaluation of this end point: 1) Weeks 4 and 12 during treatment and post-treatment Week 24 2) During treatment 3) During treatment and post-treatment Week 24 and/or 48 depending on response 4) During treatment and post-treatment; time point(s) depends on treatment assignment and response 5) Weeks 2, 4, and 12 6) Post-treatment Week 48 7) Post-treatment Week 48	—

Measure

Time frame

Secondary end point(s): Secondary Assessments (Parts A and B): 1) Proportion of HCV genotype 1 subjects with PDR. Part A PDR is defined as HCV RNA at Week 4 1 log(10) increase in HCV RNA over nadir or confirmed HCV RNA = LLOQ after confirmed undetectable HCV RNA while on treatment; 9) Proportion of subjects with undetectable relapse, defined as HCV RNA at the end of treatment followed bydetectable levels of HCV RNA in any follow-up visit window. Detectable measurements should be confirmed with 2 weeks of receipt of the initial HCV RNA result.;Timepoint(s) of evaluation of this end point: 1) Weeks 4 and 12 during treatment and post-treatment Week 24 2) During treatment 3) During treatment and post-treatment Week 24 and/or 48 depending on response 4) During treatment and post-treatment; time point(s) depends on treatment assignment and response 5) Weeks 2, 4, and 12 6) Post-treatment Week 48 7) Post-treatment Week 48

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Countries

Australia, France, Germany, Italy, Japan, New Zealand, Puerto Rico, Spain, United States

Contacts

Public ContactEU Study Start Up Unit

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026