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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This study has been withdrawn prior to enrollment.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
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 ]
  • 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 ]

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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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:
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

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

ClinicalTrials.gov processed this record on February 23, 2017