Safety and Efficacy Study of Pegylated Interferon Lambda with and without Daclatasvir, compared to Pegylated Interferon Alfa, plus Ribavirin in Subjects with Hepatitis C Genotype 2 and 3

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects Revised Protocol 02 incorporating Protocol Amendment 06 dated 19-Mar-2013 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 30-Mar12) - The PRINCIPAL study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004885-14-GB

Enrollment

1250

Registered

2012-05-28

Start date

2012-11-20

Completion date

Unknown

Last updated

2019-06-30

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: 16.0 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Chronic hepatitis C, Genotype 2 or 3 • Naïve to prior anti-HCV therapy Additional UK-specific contraception requirements (per Protocol Amendment 04): (1) Acceptable methods of highly effective birth control for WOCBP include: • Condom with spermicide • Diaphragm and spermicide • Cervical cap and spermicide • Vasectomized male partner for a minimum of 6 months (2) Two highly effective forms of contraception should be used by sexually active men and/or their partners if they are WOCBP. (3) Acceptable methods of contraception for males are: • Condom plus spermicide OR, • Vasectomy for at least 6 months and with a history of confirmed azoospermia 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 1125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125

Exclusion criteria

Exclusion criteria: • Infected with HCV other than Genotype 2 or 3, mixed genotypes are not allowed • Positive HBsAg, or HIV-1/HIV-2 antibody • Evidence of liver disease other than HCV • Active substance abuse • Evidence of decompensated cirrhosis Additional UK-specific requirements (per Protocol Amendment 04): Subjects with ophthalmologic disorders considered clinically significant on eye (including retinal) exam.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection: • SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-2a/RBV • SVR12 following 12 weeks of treatment with Lambda/RBV/DCV and the SVR12 following 24 weeks of treatment with alfa-2a/RBV ; Secondary Objective: • Evaluate Rapid virologic response (RVR) by treatment group • Evaluate the safety of 24 weeks of treatment with Lambda/RBV and 12 weeks of treatment with Lambda/RBV/DCV compared to 24 weeks of treatment with alfa-2a/RBV in reducing treatment emergent cytopenic abnormalities • Evaluate the following on-treatment IFN-associated symptoms following 24 weeks of treatment with Lambda/RBV and 12 weeks of treatment with Lambda/RBV/DCV compared to 24 weeks of treatment with alfa-2a/RBV: - Flu-like symptoms - Musculoskeletal symptoms • Evaluate SVR24 by treatment group • Evaluate, by treatment group, safety as measured by the frequency of dose reductions, discontinuations due to adverse events (AEs), and serious adverse events (SAEs) • Evaluate SVR12, by treatment group, in subjects with GT-3 chronic HCV infection • Evaluate on-treatment IFN-associated constitutional symptoms ;Primary end point(s): The primary efficacy endpoint is the proportion of chronically infected genotype 2 and 3 subjects who achieve SVR12.;Timepoint(s) of evaluation of this end point: Post-treatment week 12	—

Measure

Time frame

Main Objective: The primary objective is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection: • SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-2a/RBV • SVR12 following 12 weeks of treatment with Lambda/RBV/DCV and the SVR12 following 24 weeks of treatment with alfa-2a/RBV ; Secondary Objective: • Evaluate Rapid virologic response (RVR) by treatment group • Evaluate the safety of 24 weeks of treatment with Lambda/RBV and 12 weeks of treatment with Lambda/RBV/DCV compared to 24 weeks of treatment with alfa-2a/RBV in reducing treatment emergent cytopenic abnormalities • Evaluate the following on-treatment IFN-associated symptoms following 24 weeks of treatment with Lambda/RBV and 12 weeks of treatment with Lambda/RBV/DCV compared to 24 weeks of treatment with alfa-2a/RBV: - Flu-like symptoms - Musculoskeletal symptoms • Evaluate SVR24 by treatment group • Evaluate, by treatment group, safety as measured by the frequency of dose reductions, discontinuations due to adverse events (AEs), and serious adverse events (SAEs) • Evaluate SVR12, by treatment group, in subjects with GT-3 chronic HCV infection • Evaluate on-treatment IFN-associated constitutional symptoms ;Primary end point(s): The primary efficacy endpoint is the proportion of chronically infected genotype 2 and 3 subjects who achieve SVR12.;Timepoint(s) of evaluation of this end point: Post-treatment week 12

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: From Day 1 through 24 weeks post end treatment; Secondary end point(s): • Proportion of subjects with RVR • Proportion of subjects with treatment emergent cytopenic abnormalities • Proportion of subjects with on-treatment interferon-associated flu-like symptoms • Proportion of subjects with on-treatment musculoskeletal symptoms • Proportion of subjects with SVR24 by treatment group • Proportion of subjects with on-treatment SAEs • Proportion of subjects with dose reductions • Proportion of subjects who discontinue due to AEs • Proportion of subjects with SVR12 in subjects with GT-3 chronic HCV infection • Proportion of subjects with on-treatment constitutional symptoms	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: From Day 1 through 24 weeks post end treatment; Secondary end point(s): • Proportion of subjects with RVR • Proportion of subjects with treatment emergent cytopenic abnormalities • Proportion of subjects with on-treatment interferon-associated flu-like symptoms • Proportion of subjects with on-treatment musculoskeletal symptoms • Proportion of subjects with SVR24 by treatment group • Proportion of subjects with on-treatment SAEs • Proportion of subjects with dose reductions • Proportion of subjects who discontinue due to AEs • Proportion of subjects with SVR12 in subjects with GT-3 chronic HCV infection • Proportion of subjects with on-treatment constitutional symptoms

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Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, Finland, France, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Puerto Rico, Russian Federation, Singapore, Taiwan, United Kingdom, 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