Evaluating a new gene therapy for chronic hepatitis B
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)
Run by Precision BioSciences, Inc. · NCT06680232 · Data updated 2026-11-12
This study is testing a new gene therapy for adults with chronic hepatitis B to see if it is safe and effective in fighting the virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Precision BioSciences, Inc. Industry-sponsored |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Status | Recruiting |
| Started | November 14, 2024 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT06680232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult males and females of non-childbearing potential who have been diagnosed with chronic hepatitis B for at least 12 months and are currently virologically suppressed on nucleos(t)ide analog treatment.
✕Probably not a fit
Patients with a history of liver cirrhosis, active infections, or certain malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and antiviral activity of PBGENE-HBV in adult patients suffering from chronic hepatitis B. The study will involve a dose escalation and expansion approach to determine the optimal dosage and its effects on the virus. Participants will be closely monitored for any adverse effects and the overall effectiveness of the treatment over time.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with chronic hepatitis B, potentially leading to better management of the disease.
How similar studies have gone: While gene therapy approaches for hepatitis B are emerging, this specific intervention is novel and has not been extensively tested in previous studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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
Where it's running
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Massachusetts General Hospital/Harvard University
Boston, Massachusetts, United States Recruiting -
Hospital Beaujon
Clichy, France, France Recruiting -
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong Recruiting -
ICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova Recruiting -
New Zealand Clinical Research
Auckland, New Zealand Recruiting -
ARENSIA Exploratory Medicine
Bucharest, Romania, Romania Recruiting
Show 1 more location
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Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital
Cluj-Napoca, Romania, Romania Recruiting
Study contacts
- Study coordinator: Precision Trial Manager
- Email: ELIMINATE-B@precisionbiosciences.com
- Phone: 800-371-8953
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AHB-137 for chronic hepatitis B in adults on nucleotide analogue therapy
AHB-137 is being tested to see if it is safe and effective for adults with chronic hepatitis B who are currently on nucleos(t)ide analogue therapy.
-
Oral and gum health and saliva markers in people with hepatitis B and D
This project will test whether gum inflammation and specific saliva and gum-fluid markers differ in adults with hepatitis B and D—both those taking bulevirtide and those not—compared with healthy adults.
-
Entecavir Resistance Mutations in chronic hepatitis B patients in Turkey
This study tests whether entecavir resistance mutations can be detected in adults with chronic hepatitis B, and whether prior lamivudine exposure increases the chance of those mutations appearing.
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AHB-137 for HBeAg-negative chronic hepatitis B in the Asia–Pacific
This trial tests whether AHB-137 injections can improve outcomes for adults in the Asia–Pacific with HBeAg-negative chronic hepatitis B who are already on nucleos(t)ide therapy.
-
Sequential PEG-IFN for Hepatitis B After RNA-targeted Therapy
This study tests whether starting or delaying a 24-week course of pegylated interferon helps people with chronic hepatitis B who previously used ASO/siRNA therapies.
-
Detecting HBsAg Reversion in Hepatitis B Patients
This study is testing how well a new blood test can find if hepatitis B patients who have stopped treatment might have their virus levels come back after being cleared.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.