Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
Status: | Terminated |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/5/2017 |
Start Date: | December 9, 2014 |
End Date: | August 14, 2017 |
A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the
HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only
individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only
individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
Key Inclusion Criteria:
- Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more
than 120 days prior to Baseline (Day 1), except for participants from previous
Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their
last visit in that protocol.
- Must have the ability to understand and sign a written informed consent form, which
must be obtained prior to initiation of study procedures
- Must be willing and able to comply with the visit schedule and study requirements
- 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
- Must have documented hepatitis B surface antigen (HBsAg) negative status anytime
during participation in GS-US-174-0149 regardless of ongoing HBV treatment
Key Exclusion Criteria:
- Patient participating or planning to participate in another clinical study with an
investigational agent
- History of clinically-significant illness or any other major medical disorder that may
interfere with follow-up, assessments or compliance with the protocol
- Believed by the Study Investigator to be inappropriate for study participation for any
reason not otherwise listed
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
17
sites
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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University of Miami A private research university with more than 15,000 students from around the...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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