Clinical Trials List
Protocol NumberAI452-016
2014-07-01 - 2018-08-31
Others
Terminated1
Study ended1
ICD-10B17.10
Acute hepatitis C without hepatic coma
ICD-10B19.20
Unspecified viral hepatitis C without hepatic coma
ICD-9070.51
Hepatitis C without mention of hepatic coma, acute or unspecified
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
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb Research and Development
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 吳毅晉 Division of General Internal Medicine
- 邱彥程 Division of General Internal Medicine
- Pin-Nan Cheng Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Chronic Hepatitis C
Objectives
Recent studies demonstrate long-term durability of virologic response with pegylated
alpha-interferon-based therapies. Comparable information is not yet available for Lambda or for
regimens combining lambda interferons, RBV, and DAAs. In this protocol, subjects will be
followed for up to approximately 3 years after the completion of their follow-up in a treatment
protocol in order to evaluate the durability of the antiviral response and to characterize the
long-term progression of liver disease after use of these novel therapeutic regimens.
Persistence of antibodies to biologic therapeutics based on endogenous proteins has potential
impact on response to retreatment with similar agents. In addition, there are theoretical concerns
about potential impact on function of the endogenous protein. In the present study, the course of
persistence or disappearance of anti-drug antibodies will be observed.
Test Drug
NA
Active Ingredient
NA
Dosage Form
NA
Dosage
NA
Endpoints
Primary: To determine the durability of virologic response in subjects treated in a previous study with
Peginterferon lambda 1-a (BMS-914143; Lambda) with or without ribavirin (RBV) and/or direct acting antiviral
agents (DAAs), 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 (parent) study.
Secondary:
To characterize the long-term progression of liver disease, as measured by laboratory indicators of hepatic
status and function, all-cause mortality, and liver-related mortality, among subjects previously treated with
Lambda (BMS-914143) with or without RBV and/or DAAs, who have HCV RNA < LOQ at the completion of
the required post-treatment follow-up in the parent study
To determine the duration of persistence of anti-Lambda antibodies in subjects who are positive for antiLambda antibodies at end of treatment (EOT) in the parent study
Peginterferon lambda 1-a (BMS-914143; Lambda) with or without ribavirin (RBV) and/or direct acting antiviral
agents (DAAs), 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 (parent) study.
Secondary:
To characterize the long-term progression of liver disease, as measured by laboratory indicators of hepatic
status and function, all-cause mortality, and liver-related mortality, among subjects previously treated with
Lambda (BMS-914143) with or without RBV and/or DAAs, who have HCV RNA < LOQ at the completion of
the required post-treatment follow-up in the parent study
To determine the duration of persistence of anti-Lambda antibodies in subjects who are positive for antiLambda antibodies at end of treatment (EOT) in the parent study
Inclution Criteria
1) Signed Informed Consent
a) Must be competent to provide informed consent and able to abide the requirements of the
long-term study.
2) Target Populations
a) Males and females age 18 and over who must have received Lambda in a previous
(parent) trial, completed participation in the previous Lambda trial, and have HCV RNA
< LOQ at the completion of the required post-treatment follow-up.
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.
b) Must enter this study within 6 months of completion of the required post-treatment
follow-up in the previous Lambda trial.
a) Must be competent to provide informed consent and able to abide the requirements of the
long-term study.
2) Target Populations
a) Males and females age 18 and over who must have received Lambda in a previous
(parent) trial, completed participation in the previous Lambda trial, and have HCV RNA
< LOQ at the completion of the required post-treatment follow-up.
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.
b) Must enter this study within 6 months of completion of the required post-treatment
follow-up in the previous Lambda trial.
Exclusion Criteria
1) Subject must not be participating in any other clinical trial excluding non-interventional
trials at the time of enrollment.
2) Subject must not have been treated with any antiviral or immunomodulatory drug for
CHC after completion of treatment in the previous study of Lambda.
3) Prisoners or subjects who are involuntarily incarcerated are excluded from participation
4) Subjects who are compulsorily detained for treatment of either a psychiatric or physical
(eg, infectious disease) illness are excluded from participation
trials at the time of enrollment.
2) Subject must not have been treated with any antiviral or immunomodulatory drug for
CHC after completion of treatment in the previous study of Lambda.
3) Prisoners or subjects who are involuntarily incarcerated are excluded from participation
4) Subjects who are compulsorily detained for treatment of either a psychiatric or physical
(eg, infectious disease) illness are excluded from participation
The Estimated Number of Participants
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Taiwan
10 participants
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Global
1000 participants
