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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525810
First received: January 11, 2012
Last updated: March 25, 2015
Last verified: March 2015
  Purpose
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 Intervention
Hepatitis C
Drug: Peginterferon Lambda-1a (BMS-914143)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Long-term progression of liver disease [ Time Frame: 24 week intervals up to 144 weeks ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]

Enrollment: 218
Study Start Date: March 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)]

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525810

  Hide Study Locations
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
Argentina
Local Institution
Mar Del Plata, Buenos Aires, Argentina, 7600
Local Institution
Rosario, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, 1119
Local Institution
Buenos Aires, Argentina, 1121
Local Institution
Buenos Aires, Argentina, 1181
Local Institution
Buenos Aires, Argentina, 1221
Australia, New South Wales
Local Institution
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
Australia, Queensland
Local Institution
Greenslopes, Queensland, Australia, 4120
Local Institution
Herston, Queensland, Australia, 4029
Local Institution
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution
Fitzroy, Victoria, Australia, 3065 VIC
Local Institution
Heidelberg, Victoria, Australia, 3084
Local Institution
Melbourne, Victoria, Australia, 3004
Local Institution
Parkville, Victoria, Australia, 3050
Austria
Local Institution
Wien, Austria, 1090
Belgium
Local Institution
Leuven, Belgium, 3000
Local Institution
Liege, Belgium, 4000
Canada, Ontario
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Finland
Local Institution
Hus, Finland, 00029
France
Local Institution
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
Germany
Local Institution
Hamburg, Germany, 20246
Local Institution
Heidelberg, Germany, 69120
Greece
Local Institution
Athens, Greece, 10676
Local Institution
Thessaloniki, Greece, 54006
Italy
Local Institution
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
Korea, Republic of
Local Institution
Busan, Korea, Republic of, 614-735
Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 44650
Netherlands
Local Institution
Amsterdam, Netherlands, 1105 AZ
Local Institution
Leiden, Netherlands, 2333 ZA
New Zealand
Local Institution
Auckland, New Zealand, 92024
Poland
Local Institution
Bialystok, Poland, 15-540
Local Institution
Krakow, Poland, 31-202
Local Institution
Wroclaw, Poland, 50-220
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00927
Romania
Local Institution
Bucharest, Romania, 50524
Local Institution
Bucuresti, Romania, 30303
Local Institution
Iasi, Romania, 700506
Local Institution
Timisoara, Romania, 300 002
Spain
Local Institution
Barcelona, Spain, 08003
Local Institution
Barcelona, Spain, 08035
Local Institution
Valencia, Spain, 46010
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01525810     History of Changes
Other Study ID Numbers: AI452-016  2011-005293-31 
Study First Received: January 11, 2012
Last Updated: March 25, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
New Zealand: Medsafe
Poland: National Institute of Medicines
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Romania: Ministry of Public Health
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on September 27, 2016