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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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