ClinicalTrials.gg
Enrolling by invitationNCT07254208ELIMINATE-BUpdated Apr 22, 2026

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

An observational study in Chronic HBV Infection, sponsored by Precision BioSciences, Inc.. Enrolling by invitation at 4 sites in 4 countries. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Precision BioSciences, Inc. · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic HBV Infection

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Keywords

  • Hepatitis B Chronic
  • Gene Therapy
  • Gene Editing
  • PBGENE-HBV
03

In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's planned enrollment of 45 is below the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Precision BioSciences, Inc. is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant has received at least 1 dose of PBGENE- product in a prior clinical study
  2. Participant, or their legally authorized representative, has provided signed .

Exclusion criteria

Exclusion Criteria:

  • N/A
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes

Interventions

  • BiologicalPBGENE-HBV

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

06

What researchers measure

Primary outcomes

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

    Delayed adverse events

    Time frame: 15 years

07

Study locations

4 sites
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Jan 2040, 169 months after the start.

Of 71 observational studies under Hepatitis B, Chronic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 99. This study's planned 169 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Nov 28, 2025
StartActual
Dec 25, 2025
Primary completionEst.
Jan 2040
CompletionEst.
Jun 2040
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07254208
Lead sponsor
Precision BioSciences, Inc.
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Dec 25, 2025
Primary completion
Jan 2040 (estimated)
Completion
Jun 2040 (estimated)
Last update
Apr 22, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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