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 September 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525810
First received: January 11, 2012
Last updated: March 28, 2013
Last verified: September 2012
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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: | 1000 |
| 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
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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 LocationsLocations
| United States, Arizona | |
| Mayo Clinic Arizona | Terminated |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| Scripps Clinic | Recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Paul J Pockros, Site 015 858-652-5495 | |
| 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, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Stuart Gordon, Site 011 248-344-2353 | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Michael Charlton, Site 012 507-284-2511 | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Andrew Muir, Site 001 919-684-2052 | |
| United States, Texas | |
| University Of Texas Health Science Center At Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Michael Fallon, Site 010 713-500-6677 | |
| St. Luke'S Episcopal Hospital - Baylor College Of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: John Moore Vierling, Site 009 832-355-8966 | |
| Va Medical Center (151) | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Boris Yoffe, Site 005 713-794-7546 | |
| Alamo Medical Research | Recruiting |
| San Antonio, Texas, United States, 78215 | |
| Contact: Eric Lawitz, Site 003 210-253-3426 | |
| United States, Utah | |
| University Of Utah Hsc | Terminated |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Metropolitan Research | Recruiting |
| Fairfax, Virginia, United States, 22031 | |
| 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, Queensland | |
| Local Institution | Recruiting |
| Greenslopes, Queensland, Australia, 4120 | |
| Contact: Site 031 | |
| Local Institution | Recruiting |
| Herston, Queensland, Australia, 4029 | |
| Contact: Site 034 | |
| Australia, South Australia | |
| Local Institution | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Contact: Site 033 | |
| Australia, Victoria | |
| Local Institution | Not yet recruiting |
| Clayton, Victoria, Australia, 3168 | |
| Contact: Site 0071 | |
| Local Institution | Recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Contact: Site 0063 | |
| Local Institution | Recruiting |
| Melbourne, Victoria, Australia, 3050 | |
| Contact: Site 036 | |
| Austria | |
| Local Institution | Recruiting |
| Wien, Austria, 1090 | |
| Contact: Site 040 | |
| Canada, Ontario | |
| Local Institution | Not yet recruiting |
| Vaughan, Ontario, Canada, L4L 4Y7 | |
| Contact: Site 045 | |
| France | |
| Local Institution | Recruiting |
| Paris Cedex 12, France, 75571 | |
| Contact: Site 021 | |
| Local Institution | Not yet recruiting |
| Pessac, France, 33604 | |
| Contact: Site 022 | |
| 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 |
| Viale Del Policlinico, 155, Italy, 00161 | |
| Contact: Site 046 | |
| 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 | 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: | March 28, 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 May 22, 2013