A Long-term Observational Study in Participants Who Have Received PBGENE-HBV, an In Vivo Gene Editing Investigational Product, in a Prior Clinical Study

Precision BioSciences, Inc.

Summary

Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.

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.

Eligibility

Age range: 19–80 years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Interventions

Biological
PBGENE-HBV
PBGENE-HBV is the investigational product administered in the parent study. This LTFU study is non-interventional; no investigational product given.

Locations (4)

Massachusetts General Hospital/Harvard University
Boston, Massachusetts
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
ICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand