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

This study is currently recruiting participants.
Verified November 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525810
First received: January 11, 2012
Last updated: November 25, 2013
Last verified: November 2013
  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 ]

Estimated Enrollment: 850
Study Start Date: March 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525810

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, California
Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Paul J Pockros, Site 015    619-554-2394      
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: R. Douglas Bruce, Site 0064    203-785-4796      
United States, Florida
Local Institution Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Site 0088         
United States, Georgia
Local Institution Not yet recruiting
Marietta, Georgia, United States, 30060
Contact: Site 0090         
United States, Hawaii
Local Institution Not yet recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site 0098         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Stuart Gordon, Site 011    313-876-2972      
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Russell H Wiesner, Site 012    212-746-4495      
United States, North Carolina
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Local Institution Not yet recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site 0089         
United States, Texas
Local Institution Not yet recruiting
Arlington, Texas, United States, 76012
Contact: Site 0110         
St. Luke'S Episcopal Hospital - Baylor College Of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: John Moore Vierling, Site 009    832-355-8966      
University Of Texas Health Science Center At Houston Recruiting
Houston, Texas, United States, 77030
Contact: Michael Fallon, Site 010    713-500-8360      
Va Medical Center (151) Recruiting
Houston, Texas, United States, 77030
Contact: Boris Yoffe, Site 005    713-794-7546      
Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric Lawitz, Site 003    800-278-2571      
United States, Utah
Local Institution Not yet recruiting
Murray, Utah, United States, 84123
Contact: Site 0087         
United States, Virginia
Metropolitan Research Recruiting
Annandale, Virginia, United States, 22003
Contact: Vinod K Rustgi, Site 002    703-698-9254      
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Kris Kowdley, Site 014    206-341-0845      
Australia, New South Wales
Local Institution Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Site 0081         
Local Institution Not yet recruiting
Randwick, New South Wales, Australia, 2031
Contact: Site 0083         
Local Institution Not yet recruiting
Sydney, New South Wales, Australia, 2139
Contact: Site 0086         
Australia, Queensland
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 031         
Local Institution Recruiting
Herston, Queensland, Australia, 4029
Contact: Site 034         
Local Institution Not yet recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Site 0084         
Australia, South Australia
Local Institution Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Site 033         
Australia, Victoria
Local Institution Not yet recruiting
Clayton Vic, Victoria, Australia, 3168
Contact: Site 0071         
Local Institution Not yet recruiting
Fitzroy, Victoria, Australia, 3065 VIC
Contact: Site 0082         
Local Institution Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0063         
Local Institution Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Site 0080         
Local Institution Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Site 036         
Local Institution Not yet recruiting
Parkville, Victoria, Australia, 3050
Contact: Site 0085         
Austria
Local Institution Recruiting
Wien, Austria, 1090
Contact: Site 040         
Belgium
Local Institution Not yet recruiting
Leuven, Belgium, 3000
Contact: Site 0109         
Local Institution Not yet recruiting
Liege, Belgium, 4000
Contact: Site 0111         
Canada, Ontario
Local Institution Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Contact: Site 045         
Finland
Local Institution Not yet recruiting
Hus, Finland, 00029
Contact: Site 0108         
France
Local Institution Recruiting
Clichy Cedex, France, 92118
Contact: Site 0067         
Local Institution Not yet recruiting
Creteil Cedex, France, 9410
Contact: Site 0069         
Local Institution Recruiting
Montpellier Cedex 5, France, 34295
Contact: Site 0068         
Local Institution Recruiting
Nice Cedex 03, France, 06202
Contact: Site 0065         
Local Institution Recruiting
Paris Cedex 12, France, 75571
Contact: Site 021         
Local Institution Not yet recruiting
Paris Cedex 14, France, 75679
Contact: Site 0066         
Local institution Suspended
Pessac, France, 33604
Germany
Local Institution Recruiting
Hamburg, Germany, 20246
Contact: Site 044         
Local Institution Recruiting
Heidelberg, Germany, 69120
Contact: Site 043         
Italy
Local Institution Recruiting
Cisanello (pisa), Italy, 56124
Contact: Site 047         
Local Institution Not yet recruiting
Firenze, Italy, 50134
Contact: Site 0075         
Local Institution Not yet recruiting
Milano, Italy, 20142
Contact: Site 0073         
Local Institution Not yet recruiting
Milano, Italy, 20122
Contact: Site 0077         
Local Institution Not yet recruiting
Napoli, Italy, 80138
Contact: Site 0076         
Local Institution Not yet recruiting
Novara, Italy, 28100
Contact: Site 0074         
Local Institution Recruiting
Viale Del Policlinico, 155, Italy, 00161
Contact: Site 046         
Netherlands
Local Institution Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Site 0112         
Local Institution Not yet recruiting
Leiden, Netherlands, 2333 ZA
Contact: Site 0113         
New Zealand
Local Institution Not yet recruiting
Auckland, New Zealand, 92024
Contact: Site 0070         
Poland
Local Institution Recruiting
Bialystok, Poland, 15-540
Contact: Site 017         
Local Institution Recruiting
Krakow, Poland, 31-202
Contact: Site 018         
Local Institution Recruiting
Wroclaw, Poland, 50-220
Contact: Site 019         
Puerto Rico
Local Institution Not yet recruiting
San Juan, Puerto Rico, 00927
Contact: Site 004         
Romania
Local Institution Recruiting
Bucharest, Romania, 50524
Contact: Site 038         
Local Institution Recruiting
Bucuresti, Romania, 30303
Contact: Site 029         
Local Institution Recruiting
Iasi, Romania, 700506
Contact: Site 028         
Local Institution Recruiting
Timisoara, Romania, 300 002
Contact: Site 026         
Spain
Local Institution Active, not recruiting
Barcelona, Spain, 08035
Local Institution Active, not recruiting
Barcelona, Spain, 08003
Local Institution Active, not recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

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: November 25, 2013
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, Chronic
Hepatitis C
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 April 15, 2014