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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525810
• Other study ID #: AI452-016
• Secondary ID: 2011-005293-31
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: March 25, 2015
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilAustria: Federal Office for Safety in Health CareCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of HealthItaly: Ministry of HealthItaly: National Bioethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthItaly: The Italian Medicines AgencyNew Zealand: MedsafePoland: National Institute of MedicinesPoland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRomania: Ministry of Public HealthSpain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon Lambda-1a (BMS-914143)
Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)]

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Greenslopes	Queensland
Australia	Local Institution	Heidelberg	Victoria
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	Randwick	New South Wales
Australia	Local Institution	Sydney	New South Wales
Australia	Local Institution	Westmead	New South Wales
Australia	Local Institution	Woolloongabba	Queensland
Austria	Local Institution	Wien
Belgium	Local Institution	Leuven
Belgium	Local Institution	Liege
Canada	Toronto Digestive Disease Associates, Inc.	Vaughan	Ontario
Finland	Local Institution	Hus
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil Cedex
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Nice Cedex 03
France	Local Institution	Paris Cedex 12
France	Local Institution	Paris Cedex 14
France	Local Institution	Pessac
Germany	Local Institution	Hamburg
Germany	Local Institution	Heidelberg
Greece	Local Institution	Athens
Greece	Local Institution	Thessaloniki
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Firenze
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Novara
Italy	Local Institution	Viale Del Policlinico, 155
Korea, Republic of	Local Institution	Busan
Mexico	Local Institution	Guadalajara	Jalisco
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Leiden
New Zealand	Local Institution	Auckland
Poland	Local Institution	Bialystok
Poland	Local Institution	Krakow
Poland	Local Institution	Wroclaw
Puerto Rico	Local Institution	San Juan
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucuresti
Romania	Local Institution	Iasi
Romania	Local Institution	Timisoara
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Valencia
United States	Metropolitan Research	Annandale	Virginia
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Consultants For Clinical Research	Cincinnati	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	The Queen'S Medical Center	Honolulu	Hawaii
United States	St. Luke'S Episcopal Hospital - Baylor College Of Medicine	Houston	Texas
United States	University Of Texas Health Science Center At Houston	Houston	Texas
United States	Va Medical Center (151)	Houston	Texas
United States	Scripps Clinic	La Jolla	California
United States	Gastrointestinal Specialists Of Georgia	Marietta	Georgia
United States	Clinical Research Centers Of America	Murray	Utah
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Orlando Immunology Center	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Texas Liver Institute	San Antonio	Texas
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Finland,  France,  Germany,  Greece,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Poland,  Puerto Rico,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durability of virologic response (time to loss of virologic response)	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	24 week intervals from end of treatment in parent study up to 144 weeks	No
Secondary	Long-term progression of liver disease	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	24 week intervals up to 144 weeks	No
Secondary	Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study		24 week intervals up to 144 weeks	No

External Links

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