Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection

• Status: Terminated
• Trial end date: 2017-08-14
• Target enrollment: 0
• Participant gender: All

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 were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir; Vesatolimod

Criteria

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.