The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are:
• The proportion of subjects with at least one DRM loss from Enrollment to End
of Study by treatment regimen.
Secondary outcome
The secondary endpoints are:
• Proportion of subjects with DRM loss by unit category, 1, 2, 3,*n, by
treatment regimen;
• Average number of DRM loss by treatment regimen;
• Liver Disease progression, as assessed by clinical and laboratory parameters;
• The proportion of subjects who develop HCC through Week 144 by treatment
regimen.
Background summary
See Protocol, page 9, section 1.1 Background
Study objective
The primary objective of this Registry is:
• To evaluate HCV viral sequences and the persistence or evolution of treatment
emergent viral mutations in subjects who fail to achieve an SVR after treatment
with a Gilead oral antiviral containing regimen in a previous Gilead-sponsored
hepatitis C study.
The secondary objectives of this Registry are:
• To assess clinical progression of liver disease;
• To screen for the development of hepatocellular carcinoma (HCC).
The exploratory objective of this Registry is:
• To assess quality of life following treatment in a Gilead-sponsored hepatitis
C study.
Study design
This Registry will enroll subjects who failed to achieve an SVR after receiving
at least one Gilead oral antiviral agent (OAV) while participating in a
Gilead-sponsored hepatitis C clinical trial. The definition of failure to
achieve an SVR is defined in the Gilead-sponsored treatment protocol, however,
this Registry aims to include subjects whose HCV RNA:
• Failed to drop below the Lower Limit of Quantification (LLoQ) on treatment;
• Dropped below the LLoQ and then had a confirmed value above the LLoQ during
treatment (breakthrough);
• Dropped below the LLoQ and then had a confirmed value above the LLoQ during
the post-treatment follow-up period (relapse).
Once enrolled, subjects will be followed for up to 3 years. Clinic visits will
occur at Baseline and at Weeks 12, 24, 36, 48, 96 and 144. At each visit,
subjects will have blood drawn for plasma HCV RNA quantification, viral
sequencing, liver function tests, platelets, coagulation test, α-fetoprotein,
and a quality of life survey will be completed.
Viral sequences to be evaluated will be based on the specific antiviral
agent(s) that the subject was treated with during the initial Gilead-sponsored
treatment protocol.
Study burden and risks
Not applicable
Lakeside Drive 333
Foster City CA 94404
US
Lakeside Drive 333
Foster City CA 94404
US
Listed location countries
Age
Inclusion criteria
1 Willing and able to provide written, informed consent;
2 Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent;
3 Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol;
4 Be willing and able to comply with the visit schedule and protocol-mandated procedures.
Exclusion criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this Registry:
1. Subject is currently receiving or plans to start a new course of hepatitis C therapy including any investigational drug or medical device during the course of the follow-up Registry.
2. History of clinically-significant illness or any other major medical disorder that may interfere with
subject follow-up assessments or compliance with the protocol.
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 | EUCTR2011-000946-39-NL |
| CCMO | NL42282.018.12 |