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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01525810




Registration number
NCT01525810
Ethics application status
Date submitted
11/01/2012
Date registered
3/02/2012
Date last updated
26/03/2015

Titles & IDs
Public title
Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial
Scientific 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
Secondary ID [1] 0 0
2011-005293-31
Secondary ID [2] 0 0
AI452-016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Peginterferon Lambda-1a (BMS-914143)

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


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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 week intervals from end of treatment in parent study up to 144 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
24 week intervals up to 144 weeks
Secondary outcome [2] 0 0
Duration of persistence of anti-Lambda antibodies in subjects who are positive for anti-Lambda antibodies at end of treatment in the parent study
Timepoint [2] 0 0
24 week intervals up to 144 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Darlinghurst
Recruitment hospital [3] 0 0
Local Institution - Randwick
Recruitment hospital [4] 0 0
Local Institution - Sydney
Recruitment hospital [5] 0 0
Local Institution - Westmead
Recruitment hospital [6] 0 0
Local Institution - Greenslopes
Recruitment hospital [7] 0 0
Local Institution - Herston
Recruitment hospital [8] 0 0
Local Institution - Woolloongabba
Recruitment hospital [9] 0 0
Local Institution - Adelaide
Recruitment hospital [10] 0 0
Local Institution - Fitzroy
Recruitment hospital [11] 0 0
Local Institution - Heidelberg
Recruitment hospital [12] 0 0
Local Institution - Melbourne
Recruitment hospital [13] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2139 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4029 - Herston
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [11] 0 0
3084 - Heidelberg
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Austria
State/province [16] 0 0
Wien
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liege
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Finland
State/province [20] 0 0
Hus
Country [21] 0 0
France
State/province [21] 0 0
Clichy Cedex
Country [22] 0 0
France
State/province [22] 0 0
Creteil Cedex
Country [23] 0 0
France
State/province [23] 0 0
Montpellier Cedex 5
Country [24] 0 0
France
State/province [24] 0 0
Nice Cedex 03
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 12
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 14
Country [27] 0 0
France
State/province [27] 0 0
Pessac
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Heidelberg
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Greece
State/province [31] 0 0
Thessaloniki
Country [32] 0 0
Italy
State/province [32] 0 0
Cisanello (pisa)
Country [33] 0 0
Italy
State/province [33] 0 0
Firenze
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Napoli
Country [36] 0 0
Italy
State/province [36] 0 0
Novara
Country [37] 0 0
Italy
State/province [37] 0 0
Viale Del Policlinico, 155
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Busan
Country [39] 0 0
Mexico
State/province [39] 0 0
Jalisco
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Leiden
Country [42] 0 0
New Zealand
State/province [42] 0 0
Auckland
Country [43] 0 0
Poland
State/province [43] 0 0
Bialystok
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Poland
State/province [45] 0 0
Wroclaw
Country [46] 0 0
Puerto Rico
State/province [46] 0 0
San Juan
Country [47] 0 0
Romania
State/province [47] 0 0
Bucharest
Country [48] 0 0
Romania
State/province [48] 0 0
Bucuresti
Country [49] 0 0
Romania
State/province [49] 0 0
Iasi
Country [50] 0 0
Romania
State/province [50] 0 0
Timisoara
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01525810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications