NCT07254208

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
172mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach
4 countries

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Dec 2025Jun 2040

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2040

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2040

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

14 years

First QC Date

November 19, 2025

Last Update Submit

April 21, 2026

Conditions

Chronic HBV Infection

Keywords

Hepatitis B ChronicGene TherapyGene EditingPBGENE-HBV

Outcome Measures

Primary Outcomes (1)

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

    Delayed adverse events

    15 years

Interventions

PBGENE-HBVBIOLOGICAL

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

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Massachusetts General Hospital/Harvard University

Boston, Massachusetts, 02114, United States

Location

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong, Hong Kong

Location

ICS ARENSIA Exploratory Medicine SRL

Chisinau, Moldova, 2025, Moldova

Location

New Zealand Clinical Research

Auckland, New Zealand, 1010, New Zealand

Location

Related Links

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

December 25, 2025

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

June 1, 2040

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)NZ(1)US(1)HK(1)