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

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.
 
ClinicalTrials.gov Identifier: NCT01447394
Recruitment Status : Withdrawn
First Posted : October 6, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 4, 2011
First Posted Date  ICMJE October 6, 2011
Last Update Posted Date February 3, 2012
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01447394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus (HCV)
Intervention  ICMJE
  • Biological: Pegylated Interferon Lambda
    Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
    Other Name: BMS-914143
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1: Pegylated Interferon Lambda + Ribavirin
    Interventions:
    • Biological: Pegylated Interferon Lambda
    • Drug: Ribavirin
  • Active Comparator: Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
    Interventions:
    • Biological: Pegylated Interferon Alfa-2a
    • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 2, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2011)
900
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   China,   Colombia,   Czech Republic,   Egypt,   Hong Kong,   Hungary,   India,   Ireland,   Korea, Republic of,   Netherlands,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01447394
Other Study ID Numbers  ICMJE AI452-013
2011-003748-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP