Chronic HBV Infection
Conditions
Keywords
Hepatitis B Chronic, Gene Therapy, Gene Editing, PBGENE-HBV
Brief summary
Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
Detailed description
This is a LTFU observational study designed to evaluate the safety of PBGENE-HBV in participants previously exposed to PBGENE-HBV. This study protocol does not include administration of PBGENE-HBV.
Interventions
PBGENE-HBV is the investigational product administered in the parent study. This LTFU study is non-interventional; no investigational product given.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Participant has received at least 1 dose of PBGENE-HBV investigational product in a prior clinical study 2. Participant, or their legally authorized representative, has provided signed informed consent.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety to assess frequency, severity, and outcome of delayed adverse events | 15 years | Delayed adverse events |
Countries
Hong Kong, Moldova, New Zealand, United States