A Long-term Observational Study in Participants Who Have Received PBGENE-HBV

N/AEnrolling By InvitationNCT07254208

Precision BioSciences, Inc.45 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic HBV Infection

Interventions

PBGENE-HBVBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Massachusetts General Hospital/Harvard University

Boston, Massachusetts, United States

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

ICS ARENSIA Exploratory Medicine SRL

Chisinau, Moldova, Moldova

New Zealand Clinical Research

Auckland, New Zealand, New Zealand

Outcomes

Primary Outcomes

Safety to assess frequency, severity, and outcome of delayed adverse events

Delayed adverse events

Time frame: 15 years

Data from ClinicalTrials.gov

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