Status:
TERMINATED
Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Brief Summary
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 wer...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
December 9 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 14 2017
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT02258581
Start Date
December 9 2014
End Date
August 14 2017
Last Update
October 3 2017
Active Locations (37)
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1
Kaiser Permanente
Sacramento, California, United States
2
Kaiser Permanente
San Diego, California, United States
3
Kaiser Permanente
San Francisco, California, United States
4
Silicon Valley Research Institute
San Jose, California, United States