Health Condition 1: null- Chronic hepatitis B virus (HBV) HBeAgâ??negative infection
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
Gilead Sciences Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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. 4. Must have documented HBV DNA 5. Must have documented HBsAg negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment.
Exclusion criteria
Exclusion criteria: 1.Patient participating or planning 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
Primary
| Measure | Time frame |
|---|---|
| 1. For subjects who are HBsAg positive at Baseline:The proportion of subjects with serum HBsAg decline â?¥ 0.5 log10 IU/ml from Baseline at Week 48. 2. For subjects who are HBsAg negative at Baseline:The proportion of subjects who remain HBsAg negative at Week 48Timepoint: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| .The proportion of subjects with serum HBsAg decline â?¥ 0.5 log10 IU/ml from Baseline at Week 144. 2.The proportion of subjects who achieve HBsAg loss at week 48, 144. 3.The proportion of subjects who remain HBsAg negative at week 144. 4.Proportions of subjects with HBeAg loss and seroconversion at week 48. 5.Proportions of subjects with HBeAg loss and seroconversion at week 144. 6.For subjects on treatment with OAV anti-HBV, the proportion of subjects with HBV-DNA LLOQ at week 48,96,144.Timepoint: Week 48, 96,144 | — |
Countries
Australia, Canada, France, Germany, Greece, Hong Kong, India, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactPravin Moily
Klinera Corporation India
Outcome results
None listed