Evaluating a new gene therapy for chronic hepatitis B
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 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 |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Precision BioSciences, Inc. Industry-sponsored |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT06680232 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a history of liver cirrhosis, active infections, or certain malignancies may not benefit from this study.
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 performed: While gene therapy approaches for hepatitis B are emerging, this specific intervention is novel and has not been extensively tested in previous studies.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 3 other locations
- Massachusetts General Hospital/Harvard University — Boston, Massachusetts, United States (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)
Study contacts
- Study coordinator: Precision Trial Manager
- Email: ELIMINATE-B@precisionbiosciences.com
- Phone: 800-371-8953
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.