A follow up, long term Registry of Subjects Treated in Chronic Hepatitis B Infection

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 7

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.
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 5.
Must have documented HBsAg negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment.
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.

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 48	Week 48
Week 48.	Week 48

Secondary Outcome Measures

Name	Time	Method
.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.

Trial Locations

Locations (4): Global Hospital, Hyderabad
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Institute of Post Graduate Medical Education and Research, SSKM Hospitals
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Kolkata, WEST BENGAL, India
Midas Multispeciality Hospital Pvt. Ltd
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Nagpur, MAHARASHTRA, India
Nirmal Hospital Private Limited
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Surat, GUJARAT, India
Global Hospital, Hyderabad
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr Sachin Palnitkar
Principal investigator
919966789779
palnitkarsachin@gmail.com