RECRUITING

Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B

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Conditions

HEPATITIS B CHRONICGene TherapyGene EditingPBGENE-HBV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-11-14
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06680232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or women of non-child bearing potential
  2. * BMI 18.0 to 35.0
  3. * Good overall health deemed by the study Investigator
  4. * CHB infection documented at least 12 months prior to screening
  5. * HBeAg-negative CHB
  6. * Must be virologically suppressed on current NA treatment
  1. * No history of cirrhosis of the liver
  2. * 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.
  3. * No signs of hepatocellular carcinoma
  4. * Not received an organ transplant
  5. * No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
  6. * No investigational agent received within 6 months of screening

Contacts and Locations

Study Contact

Precision Trial Manager
CONTACT
800-371-8953
ELIMINATE-B@precisionbiosciences.com

Principal Investigator

Stanley Frankel, MD Medical Monitor
STUDY_DIRECTOR
Precision BioSciences, Inc.

Study Locations (Sites)

Massachusetts General Hospital/Harvard University
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Precision BioSciences, Inc.

  • Stanley Frankel, MD Medical Monitor, STUDY_DIRECTOR, Precision BioSciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-14
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-11-14
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • HEPATITIS B CHRONIC
  • Gene Therapy
  • Gene Editing
  • PBGENE-HBV

Additional Relevant MeSH Terms

  • HEPATITIS B CHRONIC