The primary objective of this Registry is:*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the parental study on the HBV serologic changes through Week 144 The secondary objective of this Registry is :*To evaluate the long…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this Registry are:
*For subjects who are HBsAg positive at Baseline:
The proportion of subjects with serum HBsAg decline * 0.5 log10 IU/ml from
Baseline at Week 48
*For subjects who are HBsAg negative at Baseline:
The proportion of subjects who remain HBsAg negative at Week 48
Secondary outcome
The secondary endpoints of this Registry are:
*For subjects who are HBsAg positive at Baseline:
The proportion of subjects with serum HBsAg decline * 0.5 log10 IU/ml from
Baseline at Week 144
The proportion of subjects who achieve HBsAg loss at Weeks 48 and 144
*For subjects who are HBsAg negative at Baseline:
The proportion of subjects who remain HBsAg negative at Week 144
*For subjects HBeAg positive at Baseline:
proportions of subjects with HBeAg loss and seroconversion at Week 48
proportions of subjects with HBeAg loss and seroconversion at Week 144
*For HBeAg positive subjects who achieved HBeAg seroconversion during the
parental study:
proportions of subjects who remain HBeAg negative and HBeAb positive at
Week 48-proportions of subjects who remain HBeAg negative and HBeAb positive at
Week 144
*For subjects on treatment with OAV anti-HBV, the proportion of subjects with
HBV-DNA < LLOQ at Weeks 48, 96 and 144
The change from Baseline in HBV DNA at Weeks 48, 96, and 144
The exploratory endpoints of this Registry are:
*For subjects on treatment with OAVs anti-HBV, the proportion of subjects with
HBV DNA < LLOQ target detected and proportion of subjects with HBV DNA < LLOQ
target not detected, at Weeks 48, 96 and 144
*Quality of Life measures in subjects who achieve HBsAg loss and in subjects
who do not achieve HBsAg loss
Background summary
See protocol page 10, 1.1 Background
Study objective
The primary objective of this Registry is:
*To evaluate the long term effects of Hepatitis B Virus (HBV) treatment of the
parental study on the HBV serologic changes through Week 144
The secondary objective of this Registry is :
*To evaluate the long term effects of HBV treatment of the parental study on
changes in HBV DNA levels through Week 144
The exploratory objective of this Registry is:
*To assess quality of life following treatment in a Gilead sponsored chronic
hepatitis B study.
Study design
This Registry will enroll subjects who were treated in a Gilead sponsored
chronic hepatitis B (CHB) study. Subjects who were treated in selected
Gilead-sponsored studies for CHB are eligible to participate in this Registry.
In order to manage the total study enrollment, Gilead Sciences, Inc. will
determine which treatment protocols and sites to include in this Registry
study. At its sole discretion, Gilead may at any time discontinue enrollment,
suspend screening, and/or early withdraw individual subjects from individual
treatment protocols prior to study completion (upon written notice to the site)
regardless of the progress or outcome of the protocol assessments performed.
Once enrolled, subjects will be followed for up to 144 weeks (three years). A
Baseline visit will be scheduled within 120 days from the final visit of the
parental protocol, except for subjects from previous Gilead-sponsored study
number GS-US-174-0149, who will have up to one year from their last visit in
that protocol. Clinic visits will occur at Baseline (Day 1) and at Weeks 12,
24, 48, 72, 96, 120 and 144. For subjects from previous Gilead-sponsored study
number GS US 174 0149, a Screening visit is also required to determine
eligibility for study participation.
During the Registry, subjects* CHB treatment will be managed per standard of
care. Subjects who begin an investigational agent(s) for HBV infection during
the course of the Registry will discontinue participation in the Registry.
Intervention
not applicable
Study burden and risks
not applicable
333 Lakeside Drive nap
Foster City, CA 94404
US
333 Lakeside Drive nap
Foster City, CA 94404
US
Listed location countries
Age
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible to participate in the study.
1. Must have participated in a Gilead-sponsored CHB study no more
than 120 days prior to Baseline (Day 1), except for subjects from
previous Gilead-sponsored study number GS-US-174-0149, who
will have up to one year from their last visit in that protocol
2. Must have the ability to understand and sign a written informed
consent form, which must be obtained prior to initiation of study
procedures
3. Must be willing and able to comply with the visit schedule and
study requirements
For subjects from previous Gilead-sponsored study number
GS-US-174-0149, subjects must meet either one of the following
inclusion criteria to be eligible to participate in the study:
4. Must have documented HBV DNA < 2,000 IU/mL at time of
Screening visit, which shall occur no later than 1 year post last
study visit in GS-US-174-0149
5. Must have documented HBsAg negative status anytime during
participation in GS-US-174-0149 regardless of ongoing HBV
treatment
Exclusion criteria
Subjects who meet any of the following exclusion criteria are not
eligible to participate in the study.
1. Participating or plans to participate in another clinical study with
an investigational agent
2. History or current presence of clinically-significant illness or any
other major medical disorder that may interfere with subject
follow-up, assessments or compliance with the protocol.
3. Believed by the Study Investigator to be inappropriate for study
participation for any reason not otherwise listed
For subjects from previous Gilead-sponsored study number
GS-US-174-0149 meeting Inclusion Criteria #4, subjects who
meet the following exclusion criteria are not eligible to participate
in the study:
4. Received TDF monotherapy either as part of GS-US-174-0149
Arm C (TDF monotherapy arm) or for TDF retreatment, and have
taken any HBV antiviral therapy since completion of
GS-US-174-0149
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT0225858 |
| CCMO | NL55437.078.16 |