A Long-term Observational Study in Participants Who Have Received PBGENE-HBV (ELIMINATE-B)

April 21, 2026 updated by: Precision BioSciences, Inc.

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Queen Mary Hospital, University of Hong Kong
  • Moldova
    • Moldova
      • Chisinau, Moldova, Moldova, 2025
        • ICS ARENSIA Exploratory Medicine SRL
  • New Zealand
    • New Zealand
      • Auckland, New Zealand, New Zealand, 1010
        • New Zealand Clinical Research
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital/Harvard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety to assess frequency, severity, and outcome of delayed adverse events
Time Frame: 15 years
Delayed adverse events
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision BioSciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2025

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

June 1, 2040

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBGENE-HBV-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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