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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06680232
Registration number
NCT06680232
Ethics application status
Date submitted
24/10/2024
Date registered
8/11/2024
Date last updated
25/03/2025
Titles & IDs
Public title
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients with Chronic Hepatitis B
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Scientific 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)
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Secondary ID [1]
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PBGENE-HBV-01
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Universal Trial Number (UTN)
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Trial acronym
ELIMINATE-B
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HEPATITIS B CHRONIC
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - PBGENE-HBV
Experimental: Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV. - 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.
Treatment: Other: PBGENE-HBV
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.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety to Assess Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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Frequency of TEAEs
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Timepoint [1]
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4 weeks after final dose
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Secondary outcome [1]
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Additional Safety
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Assessment method [1]
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Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
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Timepoint [1]
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48 weeks
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Secondary outcome [2]
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Pharmacokinetics of AUC
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Assessment method [2]
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Total PBGENE-HBV exposure over time
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Timepoint [2]
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4 weeks
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Secondary outcome [3]
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Pharmacokinetics of Cmax
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Assessment method [3]
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Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
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Timepoint [3]
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4 weeks
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Secondary outcome [4]
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Pharmacokinetics of Cmin
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Assessment method [4]
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Minimum (or trough) concentration of PBGENE-HBV
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Timepoint [4]
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4 weeks
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Secondary outcome [5]
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Pharmacokinetics of half life (t1/2)
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Assessment method [5]
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Terminal half life
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Timepoint [5]
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4 weeks
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Secondary outcome [6]
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Antiviral Activity of HBsAg and Anti-HBs
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Assessment method [6]
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Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
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Timepoint [6]
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48 weeks
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Secondary outcome [7]
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Antiviral Activity of HBV DNA
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Assessment method [7]
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Changes from baseline of HBV DNA
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Timepoint [7]
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48 weeks
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
45
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
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Pok Fu Lam
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Country [2]
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Moldova, Republic of
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State/province [2]
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Chisinau
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Precision BioSciences, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06680232
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Murray A. Abramson, MD MPH, Sr. VP of Clinical Development
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Address
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Precision BioSciences, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Precision Trial Manager
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Address
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Country
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Phone
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800-371-8953
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Fax
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Email
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ELIMINATE-B@precisionbiosciences.com
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06680232
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