Chronic HBV InfectionELIMINATE-BNCT07254208
A Long-term Observational Study in Participants Who Have Received PBGENE-HBV
An observational study of Chronic HBV Infection, run by Precision BioSciences, Inc. at 4 sites in 4 countries.
Trial summary
Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic HBV Infection
- What is being tested?
- PBGENE-HBV
- How many people
- 45 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 25 Dec 2025to Jun 2040
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
Who may be able to join
- Participant has received at least 1 dose of PBGENE-HBV investigational product in a prior clinical study
- Participant, or their legally authorized representative, has provided signed informed consent.
Who cannot join
- N/A
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
United States1 site
Massachusetts General Hospital/Harvard University
Boston, Massachusetts, 02114
Hong Kong1 site
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
New Zealand1 site
New Zealand Clinical Research
Auckland, New Zealand, 1010
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic HBV Infection
- Being tested
- PBGENE-HBV
- Keywords
- Hepatitis B Chronic, Gene Therapy, Gene Editing, PBGENE-HBV
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBGENE-HBVBiological
PBGENE-HBV is the investigational product administered in the parent study. This LTFU study is non-interventional; no investigational product given.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety to assess frequency, severity, and outcome of delayed adverse events
Delayed adverse events
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start25 Dec 2025
- Primary completionJan 2040 (estimated)
- Study completionJun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HBV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Precision BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254208
- Sponsor's protocol ID
- PBGENE-HBV-02
- Acronym
- ELIMINATE-B
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Observational Study in Participants Who Have Received PBGENE-HBV, an In Vivo Gene Editing Investigational Product, in a Prior Clinical Study
- ClinicalTrials.gov ID
- NCT07254208
- Acronym / sponsor ID
- ELIMINATE-B / PBGENE-HBV-02
- Conditions
- Chronic HBV Infection
- Keywords
- Hepatitis B Chronic, Gene Therapy, Gene Editing, PBGENE-HBV
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Precision BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jun 2040 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who received at least one dose of PBGENE-HBV will be enrolled in this LTFU study.
Key inclusion criteria (2 listed)
- Participant has received at least 1 dose of PBGENE-HBV investigational product in a prior clinical study
- Participant, or their legally authorized representative, has provided signed informed consent.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBGENE-HBVPBGENE-HBV is the investigational product administered in the parent study. This LTFU study is non-interventional; no investigational product given. | Biological | – |
Primary outcome
Safety to assess frequency, severity, and outcome of delayed adverse events
Time frame: 15 years
Delayed adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Interventional Study PBGENE-HBV-01Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic HBV Infection, run by Precision BioSciences, Inc. at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Hong Kong, Moldova, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety to assess frequency, severity, and outcome of delayed adverse events (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.