HEPATITIS B CHRONICPhase 1ELIMINATE-BNCT06680232
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
A Phase 1 study testing PBGENE-HBV in people with HEPATITIS B CHRONIC, run by Precision BioSciences, Inc. at 7 sites in 6 countries.
Trial summary
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HEPATITIS B CHRONIC
- What is being tested?
- PBGENE-HBV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 14 Nov 2024to Jun 2027
- Phase
- Phase 1
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or women of non-child bearing potential
- BMI 18.0 to 35.0
- Good overall health deemed by the study Investigator
- CHB infection documented at least 12 months prior to screening
- HBeAg-negative CHB
- Must be virologically suppressed on current NA treatment
Who cannot join
- No history of cirrhosis of the liver
- No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
- No signs of hepatocellular carcinoma
- Not received an organ transplant
- No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
- No investigational agent received within 6 months of screening
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
Romania2 sites, 2 recruiting
- Recruiting
ARENSIA Exploratory Medicine
Bucharest, Romania, 021105
Anca Streinu Cercel, MD, 40722998425, anca.streinucercel@gmail.com
Coralia-Alexandra Caluian, 40727193218, coralia.caluian@arensia-em.com
- Recruiting
Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital
Cluj-Napoca, Romania, 400006
Vlad-Andrei Ichim, MD, 40751130280, vlad.ichim.ext@arensia-em.com
Emanuela Beni, 40711912839, emanuela.beni@arensia-em.com
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital/Harvard University
Boston, Massachusetts, 02114
Raymond T Chung, MD, 617-724-75, Chung.Raymond@mgh.harvard.edu
Raymond T Chung, MD
France1 site, 1 recruiting
- Recruiting
Hospital Beaujon
Clichy, France, 92110
Tarik Asselah, MD, 33140875514, tarik.asselah@aphp.fr
Stephanie Narguet, 33140875514, stephanie.narguet@aphp.fr
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Man-Fung Yuen, MBBS, MD, PhD, DSc, 852-2255 3579, mfyuen@hku.hk
Man-Fung Yuen, MBBS, MD, PhD, DSc
Moldova1 site, 1 recruiting
- Recruiting
ICS ARENSIA Exploratory Medicine SRL
Chisinau, 2025
Manager, Projects & Research Logistics, 373-78883368, alexei.haceatrean@arensia-em.com
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Auckland, 1010
Edward Gane, MD, 64-2-154-8371, EdGane@adhb.govt.nz
Sophie Townshend, Study Coordinator, 64-9-373-3474, sophie.townshend@nzcr.co.nz
About this study
Official title: A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)
This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
Read the detailed description
Refer to key Inclusion and Exclusion criteria.
- Conditions
- HEPATITIS B CHRONIC
- 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 an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.
| Study group | Role | What they receive |
|---|---|---|
| Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. | Experimental | All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort. Receives: Biological: PBGENE-HBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Frequency of TEAEs
Measured: 4 weeks after final dose
Secondary outcomes (7)
Additional Safety
Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
Measured: 48 weeks
Pharmacokinetics of AUC
Total PBGENE-HBV exposure over time
Measured: 4 weeks
Pharmacokinetics of Cmax
Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
Measured: 4 weeks
Pharmacokinetics of Cmin
Minimum (or trough) concentration of PBGENE-HBV
Measured: 4 weeks
Pharmacokinetics of half life (t1/2)
Terminal half life
Measured: 4 weeks
Antiviral Activity of HBsAg and Anti-HBs
Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
Measured: 48 weeks
Antiviral Activity of HBV DNA
Changes from baseline of HBV DNA
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start14 Nov 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS B CHRONICStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oby Sogbetun Medical Monitor, MD, Study director, Precision BioSciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680232
- Sponsor's protocol ID
- PBGENE-HBV-01
- Acronym
- ELIMINATE-B
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No