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

Gilead Sciences

Status: Terminated

Conditions: Chronic Hepatitis B

Treatments: Drug: GS-9620; Drug: Tenofovir disoproxil fumarate (TDF); Drug: GS-4774

Study type: Observational

Funder types: Industry

Identifiers

NCT02258581

2015-001050-16 (EudraCT Number)

GS-US-330-1508

Details and patient eligibility

About

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).

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.