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

Terminated

• Conditions: Chronic Hepatitis B

• Registration Number: NCT02258581
• Lead Sponsor: Gilead Sciences

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-07
• Study Start: 2014-12-09
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 241

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48	Week 48	This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportion of participants who remain HBsAg negative at Week 48	Week 48	This endpoint will be measured for participants who are HBsAg negative at baseline.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who remain HBsAg negative at Week 144	Week 144	This endpoint will be measured for participants who are HBsAg negative at baseline.
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48	Week 48	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144	Week 144	This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Change from Baseline in HBV DNA at Weeks 48, 96, and 144	Baseline; Week 48; Week 96; Week 144
Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144	Week 144	This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144	Weeks 48, 96 and 144	This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48	Week 48	This endpoint will be measured for participants who are HBeAg positive at baseline.
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144	Weeks 48, 144	This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportions of participants with HBeAg loss and seroconversion at Week 144	Week 144	This endpoint will be measured for participants who are HBeAg positive at baseline.

Trial Locations

Locations (35)

Kaiser Permanente; 🇺🇸 San Francisco, California, United States

Silicon Valley Research Institute; 🇺🇸 San Jose, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

The Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Digestive Disease Associates, PA; 🇺🇸 Baltimore, Maryland, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

St. Louis University; 🇺🇸 Saint Louis, Missouri, United States

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