Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01447394
First received: October 4, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.


Condition Intervention Phase
Hepatitis C Virus (HCV)
Biological: Pegylated Interferon Lambda
Biological: Pegylated Interferon Alfa-2a
Drug: Ribavirin
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 Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response [ Time Frame: At follow-up Week 24 (SVR24) following 48 weeks of treatment ] [ Designated as safety issue: Yes ]
  • The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities [ Time Frame: From Day 1 to end of Week 48 on-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms [ Time Frame: From Day 1 to end of Week 48 on-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Pegylated Interferon Lambda + Ribavirin Biological: Pegylated Interferon Lambda
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Other Name: BMS-914143
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Name: Ribasphere
Active Comparator: Arm 2: Pegylated Interferon Alfa-2a + Ribavirin Biological: Pegylated Interferon Alfa-2a
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Name: Ribasphere

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis C, Genotype 1 or 4
  • HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
  • Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
  • Naive to prior anti-HCV therapy

Exclusion Criteria:

  • Infected with HCV other than Genotype 1 or 4
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Use of hematologic growth factors within 90 days prior to study randomization
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
  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: NCT01447394

  Show 100 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: NCT01447394     History of Changes
Other Study ID Numbers: AI452-013, 2011-003748-31
Study First Received: October 4, 2011
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration
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: Ethics Committee
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
India: Central Drugs Standard Control Organization
India: Indian Council of Medical Research
India: Ministry of Health
India: Ministry of Science and Technology
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Romania: Ministry of Public Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Turkey: Ministry of Health
Egypt: Ministry of Health and Population
Spain: Spanish Agency of Medicines
Ireland: Irish Medicines Board
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
Israel: Israeli Health Ministry Pharmaceutical Administration
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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014