Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

March 25, 2015 updated by: Bristol-Myers Squibb

A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

218

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

  • Argentina
      • Buenos Aires, Argentina, 1119
        • Local Institution
      • Buenos Aires, Argentina, 1181
        • Local Institution
      • Buenos Aires, Argentina, 1121
        • Local Institution
      • Buenos Aires, Argentina, 1221
        • Local Institution
    • Buenos Aires
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution
      • Darlinghurst, New South Wales, Australia, 2010
        • Local Institution
      • Randwick, New South Wales, Australia, 2031
        • Local Institution
      • Sydney, New South Wales, Australia, 2139
        • Local Institution
      • Westmead, New South Wales, Australia, 2145
        • Local Institution
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution
      • Herston, Queensland, Australia, 4029
        • Local Institution
      • Woolloongabba, Queensland, Australia, 4102
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Victoria
      • Fitzroy, Victoria, Australia, 3065 VIC
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
      • Parkville, Victoria, Australia, 3050
        • Local Institution
  • Austria
      • Wien, Austria, 1090
        • Local Institution
  • Belgium
      • Leuven, Belgium, 3000
        • Local Institution
      • Liege, Belgium, 4000
        • Local Institution
  • Canada
    • Ontario
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc.
  • Finland
      • Hus, Finland, 00029
        • Local Institution
  • France
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil Cedex, France, 9410
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Nice Cedex 03, France, 06202
        • Local Institution
      • Paris Cedex 12, France, 75571
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Pessac, France, 33604
        • Local Institution
  • Germany
      • Hamburg, Germany, 20246
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
  • Greece
      • Athens, Greece, 10676
        • Local Institution
      • Thessaloniki, Greece, 54006
        • Local Institution
  • Italy
      • Cisanello (pisa), Italy, 56124
        • Local Institution
      • Firenze, Italy, 50134
        • Local Institution
      • Milano, Italy, 20122
        • Local Institution
      • Milano, Italy, 20142
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Novara, Italy, 28100
        • Local Institution
      • Viale Del Policlinico, 155, Italy, 00161
        • Local Institution
  • Korea, Republic of
      • Busan, Korea, Republic of, 614-735
        • Local Institution
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution
      • Leiden, Netherlands, 2333 ZA
        • Local Institution
  • New Zealand
      • Auckland, New Zealand, 92024
        • Local Institution
  • Poland
      • Bialystok, Poland, 15-540
        • Local Institution
      • Krakow, Poland, 31-202
        • Local Institution
      • Wroclaw, Poland, 50-220
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • Romania
      • Bucharest, Romania, 50524
        • Local Institution
      • Bucuresti, Romania, 30303
        • Local Institution
      • Iasi, Romania, 700506
        • Local Institution
      • Timisoara, Romania, 300 002
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • Houston, Texas, United States, 77030
        • Va Medical Center (151)
      • San Antonio, Texas, United States, 78215
        • Texas Liver Institute
    • Utah
      • Murray, Utah, United States, 84123
        • Clinical Research Centers Of America
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Metropolitan Research
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who participated in a clinical trial in which BMS-914143 was administered for the treatment of chronic hepatitis C

Description

Inclusion Criteria:

  • Subjects must have received Lambda in a previous trial and have Hepatitis C virus (HCV) Ribonucleic acid (RNA) < LOQ at the completion of the required post-treatment follow-up (must enter this study within 6 months of completion of the required post-treatment follow-up in the previous trial) NOTE: For blinded parent trials, subjects who have HCV RNA <LOQ at the completion of the required post-treatment follow-up may enter this study without knowledge of their treatment assignment in the parent study. Subjects who received control agents (eg, pegylated-interferon alfa) in the previous protocol will be allowed to participate until unblinded treatment information is released; at that time subjects will have the option to continue in the study

Exclusion Criteria:

  • Subjects must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of the previous study of Lambda

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects treated with Peginterferon Lambda-1a (BMS-914143)
Subjects who participated in a clinical trial in which Peginterferon Lambda-1a (BMS-914143) was administered for the treatment of chronic hepatitis C
Drug: Peginterferon Lambda-1a (BMS-914143)
Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durability of virologic response (time to loss of virologic response)
Time Frame: 24 week intervals from end of treatment in parent study up to 144 weeks
Durability of virologic response as assessed by the time to loss of virologic response in subjects treated in a previous study with BMS-914143 who have HCV RNA less than the limit of quantitation of the assay (< LOQ) at the completion of the required post-treatment follow-up in the previous study. Loss of virologic response assessed using HCV RNA at 24-week intervals
24 week intervals from end of treatment in parent study up to 144 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term progression of liver disease
Time Frame: 24 week intervals up to 144 weeks
Long-term progression of liver disease as measured by laboratory indicators of hepatic status and function, all-cause mortality and liver related mortality in subjects previously treated with BMS-914143 who have HCV RNA < LOQ at the completion of the required post-treatment follow-up in the parent study
24 week intervals up to 144 weeks
Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study
Time Frame: 24 week intervals up to 144 weeks
24 week intervals up to 144 weeks

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI452-016
  • 2011-005293-31 (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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