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

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. Identifier: NCT01525810
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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

Condition or disease Intervention/treatment
Hepatitis C Drug: Peginterferon Lambda-1a (BMS-914143)

Study Type : Observational
Actual Enrollment : 218 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : March 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)]

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01525810

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

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01525810     History of Changes
Other Study ID Numbers: AI452-016
2011-005293-31 ( EudraCT Number )
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections