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

NCT07254208 — Enrolling by invitation, 45 participants, Precision BioSciences, Inc.
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A Long-term Observational Study in Participants Who Have Received PBGENE-HBV, an In Vivo Gene Editing Investigational Product, in a Prior Clinical Study

RegistryNCT07254208, acronym ELIMINATE-B
StatusEnrolling by invitation
Study typeObservational
Enrollment45 (Estimated)
SponsorPrecision BioSciences, Inc. (Industry)
ConditionsChronic HBV Infection
InterventionsPBGENE-HBV (Biological)
Datesstart 2025-12-25, primary completion 2040-01-01 (estimated), completion 2040-06-01 (estimated), first posted 2025-11-28, last updated 2026-04-22
Locations4 sites in United States, Hong Kong, Moldova, New Zealand

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-Summary

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

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • Safety to assess frequency, severity, and outcome of delayed adverse events [15 years]: Delayed adverse events

+Eligibility

Sex: All, ages: 19 Years to 80 Years

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)

FacilityCityCountryStatus
Massachusetts General Hospital/Harvard UniversityBoston, MassachusettsUnited States
Queen Mary Hospital, University of Hong KongHong Kong, Hong KongHong Kong
ICS ARENSIA Exploratory Medicine SRLChisinau, MoldovaMoldova
New Zealand Clinical ResearchAuckland, New ZealandNew Zealand