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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07254208
Acronym
ELIMINATE-B
Enrollment
45
Registered
2025-11-28
Start date
2025-12-25
Completion date
2040-06-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HBV Infection

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

BIOLOGICALPBGENE-HBV

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

Sponsors

Precision BioSciences, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Safety to assess frequency, severity, and outcome of delayed adverse events15 yearsDelayed adverse events

Countries

Hong Kong, Moldova, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026