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

February 2, 2012 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Local Institution
    • Ontario
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Local Institution
  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Local Institution
  • Colombia
      • Bogota, Colombia
        • Local Institution
      • Cali, Colombia
        • Local Institution
      • Medellin, Colombia
        • Local Institution
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Local Institution
      • Praha 4, Czech Republic, 140 21
        • Local Institution
      • Usti Nad Labem, Czech Republic, 400 01
        • Local Institution
  • Egypt
      • Cairo, Egypt, 11559
        • Local Institution
    • Menoufiya
      • Shebin Elkom, Menoufiya, Egypt, 35111
        • Local Institution
  • Hong Kong
      • Lai Chi Kok, Hong Kong
        • Local Institution
      • Tai Po, Hong Kong
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1097
        • Local Institution
      • Budapest, Hungary, 1126
        • Local Institution
      • Debrecen, Hungary, 4043
        • Local Institution
      • Miskolc, Hungary, 3529
        • Local Institution
  • India
      • Coimbatore, India, 641005
        • Local Institution
      • Gurgaon, India, 122001
        • Local Institution
      • Ludhiana, India, 141001
        • Local Institution
      • Nagpur, India, 440010
        • Local Institution
      • New Delhi, India, 110 070
        • Local Institution
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500082
        • Local Institution
  • Ireland
      • Dublin, Ireland, DUBLIN 7
        • Local Institution
    • Dublin
      • Dublin 8, Dublin, Ireland
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 609-735
        • Local Institution
      • Busan, Korea, Republic of, 614-735
        • Local Institution
      • Daegu, Korea, Republic of, 700-721
        • Local Institution
      • Incheon, Korea, Republic of, 400-711
        • Local Institution
      • Incheon, Korea, Republic of, 403-720
        • Local Institution
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
      • Seoul, Korea, Republic of, 120-752
        • Local Institution
      • Seoul, Korea, Republic of, 135-710
        • Local Institution
      • Seoul, Korea, Republic of, 138-736
        • Local Institution
      • Suwon, Korea, Republic of, 443-721
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Leiden, Netherlands, 2300
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-540
        • Local Institution
      • Bydgoszcz, Poland, 85-030
        • Local Institution
      • Chorzow, Poland, 41-500
        • Local Institution
      • Czeladz, Poland, 41-250
        • Local Institution
      • Kielce, Poland, 25-317
        • Local Institution
      • Krakow, Poland, 31-501
        • Local Institution
      • Lodz, Poland, 91-347
        • Local Institution
      • Lublin, Poland, 20-081
        • Local Institution
      • Olsztyn, Poland, 10-082
        • Local Institution
      • Pulawy, Poland, 24-100
        • Local Institution
      • Raciborz, Poland, 47-400
        • Local Institution
      • Sosnowiec, Poland, 41-200
        • Local Institution
      • Warszawa, Poland, 01-201
        • Local Institution
      • Wroclaw, Poland, 50-220
        • Local Institution
      • Zielona Gora, Poland, 65-046
        • Local Institution
  • Romania
      • Bucharest, Romania, 021105
        • Local Institution
      • Iasi, Romania, 700506
        • Local Institution
      • Timisoara, Romania, 300002
        • Local Institution
  • Russian Federation
      • Kaluga, Russian Federation, 248023
        • Local Institution
      • Lipetsk, Russian Federation, 398043
        • Local Institution
      • Moscow, Russian Federation, 111123
        • Local Institution
      • Moscow, Russian Federation, 115446
        • Local Institution
      • Moscow, Russian Federation, 117333
        • Local Institution
      • Nizhniy Novgorod, Russian Federation, 603022
        • Local Institution
      • Poselok Noviy, Russian Federation, 143420
        • Local Institution
      • Samara, Russian Federation, 443077
        • Local Institution
      • Saratov, Russian Federation, 410009
        • Local Institution
      • Smolensk, Russian Federation, 214018
        • Local Institution
      • Smolensk, Russian Federation, 214006
        • Local Institution
      • St. Petersburg, Russian Federation, 194044
        • Local Institution
      • St. Petersburg, Russian Federation, 191167
        • Local Institution
      • St. Petersburg, Russian Federation, 196645
        • Local Institution
      • St.Petersburg, Russian Federation, 193137
        • Local Institution
      • St.Petersburg, Russian Federation, 198103
        • Local Institution
      • Toliatti, Russian Federation, 445846
        • Local Institution
      • Volgograd, Russian Federation, 400040
        • Local Institution
    • Mari El
      • Ioshkar-Ola, Mari El, Russian Federation, 424006
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
      • Singapore, Singapore, 529889
        • Local Institution
      • Singapore, Singapore, 169608
        • Local Institution
      • Singapore, Singapore, 119228
        • Local Institution
  • Spain
      • A Coruna, Spain, 15006
        • Local Institution
      • Barcelona, Spain, 08035
        • Local Institution
      • Barcelona, Spain, 08036
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Local Institution
      • Kaohsiung, Taiwan, 80756
        • Local Institution
      • Taichung, Taiwan, 404
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
  • Turkey
      • Ankara, Turkey, 06100
        • Local Institution
      • Bornova Izmir, Turkey, 35100
        • Local Institution
      • Diyarbakir, Turkey, 21280
        • Local Institution
      • Istanbul, Turkey, 34093
        • Local Institution
      • Trabzon, Turkey, 61080
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, W2 1NY
        • Local Institution
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Local Institution
  • United States
    • California
      • San Diego, California, United States, 92114
        • Local Institution
    • New York
      • Rochester, New York, United States, 14642
        • Local Institution
    • Texas
      • Houston, Texas, United States, 77230
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Pegylated Interferon Lambda + Ribavirin
Biological: Pegylated Interferon Lambda
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Other Names:
  • BMS-914143
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Active Comparator: Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Other Names:
  • Ribasphere
Biological: Pegylated Interferon Alfa-2a
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
From Day 1 to end of Week 48 on-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From Day 1 to end of Week 48 on-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI452-013
  • 2011-003748-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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