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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 is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525810
First received: January 11, 2012
Last updated: October 13, 2014
Last verified: August 2014
  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
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

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, California
Scripps Clinic Completed
La Jolla, California, United States, 92037
United States, Connecticut
Yale University School Of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Orlando Immunology Center Active, not recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Gastrointestinal Specialists Of Georgia Completed
Marietta, Georgia, United States, 30060
United States, Hawaii
The Queen'S Medical Center Active, not recruiting
Honolulu, Hawaii, United States, 96813
United States, Michigan
Henry Ford Health System Completed
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Consultants For Clinical Research Active, not recruiting
Cincinnati, Ohio, United States, 45249
United States, Texas
Texas Clinical Research Institute Active, not recruiting
Arlington, Texas, United States, 76012
University Of Texas Health Science Center At Houston Completed
Houston, Texas, United States, 77030
Va Medical Center (151) Completed
Houston, Texas, United States, 77030
St. Luke'S Episcopal Hospital - Baylor College Of Medicine Completed
Houston, Texas, United States, 77030
Texas Liver Institute Active, not recruiting
San Antonio, Texas, United States, 78215
United States, Utah
Clinical Research Centers Of America Completed
Murray, Utah, United States, 84123
United States, Virginia
Metropolitan Research Completed
Annandale, Virginia, United States, 22003
United States, Washington
Virginia Mason Medical Center Active, not recruiting
Seattle, Washington, United States, 98101
Argentina
Local Institution Recruiting
Mar Del Plata, Buenos Aires, Argentina, 7600
Contact: Site 0102         
Local Institution Not yet recruiting
Rosario, Santa Fe, Argentina, 2000
Contact: Site 0100         
Local Institution Recruiting
Buenos Aires, Argentina, 1121
Contact: Site 0105         
Local Institution Recruiting
Buenos Aires, Argentina, 1181
Contact: Site 0099         
Local Institution Not yet recruiting
Buenos Aires, Argentina, 1221
Contact: Site 0103         
Local Institution Recruiting
Buenos Aires, Argentina, 1119
Contact: Site 0101         
Australia, New South Wales
Local Institution Completed
Camperdown, New South Wales, Australia, 2050
Local Institution Completed
Darlinghurst, New South Wales, Australia, 2010
Local Institution Active, not recruiting
Randwick, New South Wales, Australia, 2031
Local Institution Active, not recruiting
Sydney, New South Wales, Australia, 2139
Local Institution Completed
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Local Institution Completed
Greenslopes, Queensland, Australia, 4120
Local Institution Active, not recruiting
Herston, Queensland, Australia, 4029
Local Institution Completed
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Local Institution Completed
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution Completed
Fitzroy, Victoria, Australia, 3065 VIC
Local Institution Active, not recruiting
Heidelberg, Victoria, Australia, 3084
Local Institution Active, not recruiting
Melbourne, Victoria, Australia, 3004
Local Institution Active, not recruiting
Melbourne, Victoria, Australia, 3050
Local Institution Active, not recruiting
Parkville, Victoria, Australia, 3050
Austria
Local Institution Recruiting
Wien, Austria, 1090
Contact: Site 040         
Belgium
Local Institution Recruiting
Leuven, Belgium, 3000
Contact: Site 0109         
Local Institution Recruiting
Liege, Belgium, 4000
Contact: Site 0111         
Canada, Ontario
Toronto Digestive Disease Associates, Inc. Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Contact: Susan Greenbloom, Site 045    416-650-0017 ext 384      
Finland
Local Institution Active, not recruiting
Hus, Finland, 00029
France
Local Institution Completed
Clichy Cedex, France, 92118
Local Institution Active, not recruiting
Creteil Cedex, France, 9410
Local Institution Completed
Montpellier Cedex 5, France, 34295
Local Institution Completed
Nice Cedex 03, France, 06202
Local Institution Completed
Paris Cedex 12, France, 75571
Local Institution Active, not recruiting
Paris Cedex 14, France, 75679
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         
Greece
Local Institution Recruiting
Athens, Greece, 10676
Contact: Site 0078         
Local Institution Active, not recruiting
Thessaloniki, Greece, 54006
Italy
Local Institution Recruiting
Cisanello (pisa), Italy, 56124
Contact: Site 047         
Local Institution Recruiting
Firenze, Italy, 50134
Contact: Site 0075         
Local Institution Not yet recruiting
Milano, Italy, 20122
Contact: Site 0077         
Local Institution Not yet recruiting
Milano, Italy, 20142
Contact: Site 0073         
Local Institution Not yet recruiting
Napoli, Italy, 80131
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         
Korea, Republic of
Local Institution Completed
Busan, Korea, Republic of, 614-735
Mexico
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44650
Contact: Site 0092         
Netherlands
Local Institution Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Site 0112         
Local Institution Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Site 0113         
New Zealand
Local Institution Recruiting
Auckland, New Zealand, 92024
Contact: Site 0070         
Poland
Local Institution Active, not recruiting
Bialystok, Poland, 15-540
Local Institution Active, not recruiting
Krakow, Poland, 31-202
Local Institution Active, not recruiting
Wroclaw, Poland, 50-220
Puerto Rico
Local Institution Not yet recruiting
San Juan, Puerto Rico, 00927
Contact: Site 004         
Romania
Local Institution Completed
Bucharest, Romania, 50524
Local Institution Active, not recruiting
Bucuresti, Romania, 30303
Local Institution Active, not recruiting
Iasi, Romania, 700506
Local Institution Active, not recruiting
Timisoara, Romania, 300 002
Spain
Local Institution Active, not recruiting
Barcelona, Spain, 08035
Local Institution Completed
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: October 13, 2014
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 C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014