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Enrolling by invitation NCT07254208

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

— Observational Chronic HBV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PBGENE-HBV.
Who it may be relevant to
Registry conditions: Chronic HBV Infection. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Hong Kong, Moldova, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Safety to assess frequency, severity, and outcome of delayed adverse events [Time frame: 15 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Massachusetts General Hospital/Harvard University — Boston
Hong Kong · 1 center
  • Queen Mary Hospital, University of Hong Kong — Hong Kong
Moldova · 1 center
  • ICS ARENSIA Exploratory Medicine SRL — Chisinau
New Zealand · 1 center
  • New Zealand Clinical Research — Auckland

Identifiers

NCT: NCT07254208 · PBGENE-HBV-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗