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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01616524
First received: June 7, 2012
Last updated: October 13, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group [ Time Frame: Post-treatment week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with on-treatment Serious adverse events (SAEs) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with dose reductions [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who discontinue due to Adverse events (AEs) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection [ Time Frame: Post-treatment follow-up week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) [ Time Frame: Up to week 12 or week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 880
Study Start Date: July 2012
Estimated Study Completion Date: October 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616524

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

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01616524     History of Changes
Other Study ID Numbers: AI452-017, 2011-004885-14
Study First Received: June 7, 2012
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
New Zealand: Medsafe
Finland: Finnish Medicines Agency
Finland: Data Protection Board
Finland: National Advisory Board on Health Care Ethics
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Federal Commission for Sanitary Risks Protection
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
South Korea: Korea Food and Drug Administration (KFDA)
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs
Hong Kong: Department of Health
Brazil: National Health Surveillance Agency
Brazil: National Committee of Ethics in Research
Chile: Instituto de Salud Pública de Chile
India: Central Drugs Standard Control Organization
India: Indian Council of Medical Research
India: Ministry of Health
India: Ministry of Science and Technology
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Greece: Ethics Committee
Greece: National Organization of Medicines
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Canada: Health Canada
United States: Institutional Review Board

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
Peginterferon alfa-2a
Interferon-alpha
Interferons
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014