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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 (PRINCIPAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616524
First Posted: June 11, 2012
Last Update Posted: October 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Condition Intervention Phase
Hepatitis C Virus (HCV) Biological: Pegylated interferon lambda (pegIFNλ) Biological: Pegylated interferon alfa-2a (pegIFNα-2a) Drug: Ribavirin Drug: Daclatasvir Drug: Placebo matching Daclatasvir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) [ Time Frame: Post-treatment follow-up week 12 ]

Secondary Outcome Measures:
  • Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] [ Time Frame: On-treatment Week 4 ]
  • Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3) [ Time Frame: Up to week 12 or week 24 ]
    Hb = Hemoglobin ANC = Absolute neutrophil count

  • Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain) [ Time Frame: Up to week 12 or week 24 ]
  • Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) [ Time Frame: Up to week 12 or week 24 ]
  • Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group [ Time Frame: Post-treatment week 24 ]
  • Proportion of subjects with on-treatment Serious adverse events (SAEs) [ Time Frame: Up to week 12 or week 24 ]
  • Proportion of subjects with dose reductions [ Time Frame: Up to week 12 or week 24 ]
  • Proportion of subjects who discontinue due to Adverse events (AEs) [ Time Frame: Up to week 12 or week 24 ]
  • Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection [ Time Frame: Post-treatment follow-up week 12 ]
  • Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) [ Time Frame: Up to week 12 or week 24 ]

Enrollment: 880
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Name: BMS-914143
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Name: Ribasphere
Drug: Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Experimental: Arm 2: pegIFNλ + Ribavirin + Daclatasvir Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Other Name: BMS-914143
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Other Name: Ribasphere
Drug: Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks
Other Name: BMS-790052
Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir Biological: Pegylated interferon alfa-2a (pegIFNα-2a)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Name: Ribasphere
Drug: Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Chronic hepatitis C, Genotype 2 or 3
  • Naïve to prior anti-HCV therapy

Exclusion Criteria:

  • Infected with HCV other than Genotype 2 or 3
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Evidence of decompensated cirrhosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616524


  Show 124 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01616524     History of Changes
Other Study ID Numbers: AI452-017
2011-004885-14 ( EudraCT Number )
First Submitted: June 7, 2012
First Posted: June 11, 2012
Last Update Posted: October 9, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs