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

A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects with Chronic Hepatitis B Infection - GS-US-330-1508

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43924

Enrollment

Registered

2016-05-25

Start date

2016-06-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B inflammation of liver

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible to participate in the study. 1. Must have participated in a Gilead-sponsored CHB study no more than 120 days prior to Baseline (Day 1), except for subjects from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol 2. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures 3. Must be willing and able to comply with the visit schedule and study requirements For subjects from previous Gilead-sponsored study number GS-US-174-0149, subjects must meet either one of the following inclusion criteria to be eligible to participate in the study: 4. Must have documented HBV DNA

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following exclusion criteria are not eligible to participate in the study. 1. Participating or plans to participate in another clinical study with an investigational agent 2. History or current presence of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol. 3. Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed For subjects from previous Gilead-sponsored study number GS-US-174-0149 meeting Inclusion Criteria #4, subjects who meet the following exclusion criteria are not eligible to participate in the study: 4. 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

Design outcomes

Secondary

Measure	Time frame
The secondary endpoints of this Registry are: For subjects who are HBsAg positive at Baseline: The proportion of subjects with serum HBsAg decline 0.5 log10 IU/ml from Baseline at Week 144 The proportion of subjects who achieve HBsAg loss at Weeks 48 and 144 For subjects who are HBsAg negative at Baseline: The proportion of subjects who remain HBsAg negative at Week 144 For subjects HBeAg positive at Baseline: proportions of subjects with HBeAg loss and seroconversion at Week 48 proportions of subjects with HBeAg loss and seroconversion at Week 144 For HBeAg positive subjects who achieved HBeAg seroconversion during the parental study: proportions of subjects who remain HBeAg negative and HBeAb positive at Week 48-proportions of subjects who remain HBeAg negative and HBeAb positive at Week 144 For subjects on treatment with OAV anti-HBV, the proportion of subjects with HBV-DNA	—

Measure

Time frame

The secondary endpoints of this Registry are: *For subjects who are HBsAg positive at Baseline: The proportion of subjects with serum HBsAg decline * 0.5 log10 IU/ml from Baseline at Week 144 The proportion of subjects who achieve HBsAg loss at Weeks 48 and 144 *For subjects who are HBsAg negative at Baseline: The proportion of subjects who remain HBsAg negative at Week 144 *For subjects HBeAg positive at Baseline: proportions of subjects with HBeAg loss and seroconversion at Week 48 proportions of subjects with HBeAg loss and seroconversion at Week 144 *For HBeAg positive subjects who achieved HBeAg seroconversion during the parental study: proportions of subjects who remain HBeAg negative and HBeAb positive at Week 48-proportions of subjects who remain HBeAg negative and HBeAb positive at Week 144 *For subjects on treatment with OAV anti-HBV, the proportion of subjects with HBV-DNA

—

Primary

Measure	Time frame
The primary endpoints of this Registry are: For subjects who are HBsAg positive at Baseline: The proportion of subjects with serum HBsAg decline 0.5 log10 IU/ml from Baseline at Week 48 *For subjects who are HBsAg negative at Baseline: The proportion of subjects who remain HBsAg negative at Week 48	—

Countries

Netherlands

Outcome results