The primary objective of this Registry is:• To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored hepatitis C study.The secondary objectives of this Registry are:• To determine whether subsequent…
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 maintaining SVR at Week 144 per treatment regimen.
Secondary outcome
The secondary endpoints are:
• The proportion of subjects with detectable HCV RNA due to re-emergence of
pre-existing virus through Week 144 per treatment regimen;
• The proportion of subjects with detectable HCV resistance mutations through
Week 144 per treatment regimen;
• The proportion of subjects with detectable HCV RNA due to re-infection
through Week 144 per treatment regimen;
• Liver Disease progression, as assessed by clinical and laboratory parameters;
• The proportion of subjects who develop HCC through Week 144 per treatment
regimen.
Other endpoints of interest are:
• Route of re-infection, if known.
Background summary
See Protocol, page 9, section 1.1 Background
Study objective
The primary objective of this Registry is:
• To assess the durability of sustained virologic response (SVR) following
treatment in a Gilead-sponsored hepatitis C study.
The secondary objectives of this Registry are:
• To determine whether subsequent detection of HCV RNA in subjects who relapse
following SVR, represents the re-emergence of pre-existing virus, the
development of resistance mutations, or whether it is due to re-infection;
• 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 have achieved an SVR after receiving at
least one oral antiviral agent (OAV) while participating in a Gilead-sponsored
hepatitis C clinical trial. The definition of an SVR is defined in the initial
Gilead-sponsored treatment protocol. Once enrolled, subjects will be followed
for up to 3 years. Visits will occur at Baseline and then at Weeks 24, 48, 72,
96, 120 and 144. At each visit, subjects will have blood drawn for plasma HCV
RNA quantification, liver function tests, platelets, coagulation test, α-
fetoprotein, and a quality of life survey will be completed. If HCV RNA is
detected, the subject will have a repeat blood sample drawn for confirmation.
If HCV RNA is confirmed the subject will be withdrawn from the Registry. If the
confirmed HCV RNA is > 1000 IU/ml, viral sequence analysis will be performed.
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 (OAV);
3. Have achieved Sustained Virologic Response in a 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 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 | EUCTR2011-000945-19-NL |
| CCMO | NL42225.018.12 |