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…
ID
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
Synonym
Health condition
Hepatitis C
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
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 anti-Lambda antibodies at end of treatment (EOT) in the
parent study
Background summary
Standard treatment options for patients with Hepatitis C virus (HCV) infection
are limited. Current therapy involves 24-48 weeks of treatment with pegylated
interferon alfa2a/alfa2b (Peg) and Ribavirin (RBV). This combination has
limited effectiveness and is also poorly tolerated in some patients,
highlighting the unmet medical need for new therapeutics. Treatment with
BMS914143 is being studied with or without RBV and/or direct acting antiviral
agents (DAA) for its role as a potential treatment option in combination
therapy for patients with chronic hepatitis C (CHC). Little is known about the
longterm safety and effectiveness of this combination in suppressing HCV, after
study treatment has stopped. This study will follow patients previously treated
in any BMS914143 study, for 3 years after their participation in the previous
(*parent*) study has ended.
This study aims to assess whether the treatment received in the parent study
will continue to be effective in suppressing HCV up to 3 years after study
treatment has stopped. For patients where HCV is detected, this study will also
determine if the virus that is present is less responsive to treatment. This
study will also assess if patients liver disease worsens.
This study is designed to follow the timing of visits for patients that is
consistent with standard of care for CHC. Participating patients will attend 7
clinic visits over 3 years (approximately every 6 months). During clinic visits
patients will be asked about their lifestyle & medical history and will undergo
a short physical examination and blood test. Phone contacts are also scheduled
twice yearly. Globally, the study began in March 2012* and approximately 1000
patients will participate. In the Netherlands the study will begin in Jan2014*
approximately 50 patients will participate. The total number of patients will
increase with the addition of parent trials. The study is funded by
Bristol-Myers Squibb.
Study objective
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 re-treatment 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.
Study design
This study will follow subjects previously treated with Lambda in selected
trials, including trials of Lambda used in combination with direct acting
antiviral agents (DAAs).
Study burden and risks
Overall risk/benefit assessment
The burden, risks and potential benefits are summarised in Section E above.
Orteliuslaan 1000
Utrecht 3528 BD
NL
Orteliuslaan 1000
Utrecht 3528 BD
NL
Listed location countries
Age
Inclusion criteria
Subjects must have received BMS-914143 in a previous trial and have HCV 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).
Exclusion criteria
Subjects must not have been treated with any antiviral or immunomodulatory drug for hepatitis C after completion of the previous study of BMS-914143.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-005293-31-NL |
| CCMO | NL46905.018.14 |