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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

Titles & IDs
Public title
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients with Chronic Hepatitis B
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)
Secondary ID [1] 0 0
PBGENE-HBV-01
Universal Trial Number (UTN)
Trial acronym
ELIMINATE-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HEPATITIS B CHRONIC 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
4 weeks after final dose
Secondary outcome [1] 0 0
Additional Safety
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Pharmacokinetics of AUC
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
Pharmacokinetics of Cmax
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
Pharmacokinetics of Cmin
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Pharmacokinetics of half life (t1/2)
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Antiviral Activity of HBsAg and Anti-HBs
Timepoint [6] 0 0
48 weeks
Secondary outcome [7] 0 0
Antiviral Activity of HBV DNA
Timepoint [7] 0 0
48 weeks

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

Key
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Pok Fu Lam
Country [2] 0 0
Moldova, Republic of
State/province [2] 0 0
Chisinau
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Precision BioSciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Murray A. Abramson, MD MPH, Sr. VP of Clinical Development
Address 0 0
Precision BioSciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Precision Trial Manager
Address 0 0
Country 0 0
Phone 0 0
800-371-8953
Fax 0 0
Email 0 0
ELIMINATE-B@precisionbiosciences.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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