Clinical trial NCT01525810: Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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


Eligibility 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

Primary outcomes:
measure: Durability of virologic response (time to loss of virologic response)
timeFrame: 24 week intervals from end of treatment in parent study up to 144 weeks
Secondary outcomes:
measure: Long-term progression of liver disease
timeFrame: 24 week intervals up to 144 weeks
measure: Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study
timeFrame: 24 week intervals up to 144 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia
state: Georgia
city: Honolulu
country: United States
facility: The Queen'S Medical Center
state: Hawaii
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research
state: Ohio
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Houston
country: United States
facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine
state: Texas
city: Houston
country: United States
facility: University Of Texas Health Science Center At Houston
state: Texas
city: Houston
country: United States
facility: Va Medical Center (151)
state: Texas
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
city: Murray
country: United States
facility: Clinical Research Centers Of America
state: Utah
city: Annandale
country: United States
facility: Metropolitan Research
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Mar Del Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Wien
country: Austria
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Liege
country: Belgium
facility: Local Institution
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc.
state: Ontario
city: Hus
country: Finland
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Nice Cedex 03
country: France
facility: Local Institution
city: Paris Cedex 12
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Thessaloniki
country: Greece
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Novara
country: Italy
facility: Local Institution
city: Viale Del Policlinico, 155
country: Italy
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Auckland
country: New Zealand
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Bucharest
country: Romania
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Iasi
country: Romania
facility: Local Institution
city: Timisoara
country: Romania
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: