PBGENE-HBV for Chronic Hepatitis B
(ELIMINATE-B Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called PBGENE-HBV for individuals with chronic hepatitis B, a long-term liver infection caused by the hepatitis B virus. The main goal is to assess the safety and effectiveness of this treatment and its behavior in the body. Participants will receive varying doses to determine the optimal one. Individuals with hepatitis B who have been on stable medication and have had the infection for at least a year may be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial requires that participants are already virologically suppressed on their current NA (nucleos(t)ide analog) treatment, so you will need to continue taking your current medication for chronic hepatitis B.
Is there any evidence suggesting that PBGENE-HBV is likely to be safe for humans?
A previous study showed that early safety results for PBGENE-HBV indicated the treatment was generally well-tolerated by patients. Reports indicate that participants experienced no severe side effects. Ongoing research suggests it is safe to increase the dose and administer multiple doses. Although PBGENE-HBV remains in the early stages of testing, these findings are promising for its safety in humans. It is important to note that this treatment is still under study, and more information will become available as research progresses.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about PBGENE-HBV because it offers a new approach to treating chronic Hepatitis B. Unlike standard therapies like nucleos(t)ide analogs and pegylated interferon, which primarily work by suppressing the virus, PBGENE-HBV is delivered through multiple intravenous doses in a way that aims to reduce the viral load more effectively. This treatment could potentially lead to a more sustained response or even a functional cure, which is a significant advancement over current options that require long-term management. The innovative delivery method and potential for a finite course of treatment make PBGENE-HBV a compelling option for future Hepatitis B care.
What evidence suggests that PBGENE-HBV might be an effective treatment for chronic hepatitis B?
Research has shown that PBGENE-HBV effectively lowers the levels of a specific protein linked to chronic hepatitis B. In early studies, every participant experienced a noticeable drop in this protein after receiving PBGENE-HBV. The treatment was well-tolerated and demonstrated strong activity after three doses, indicating its potential as a promising antiviral option. Initial results revealed that two out of three patients saw a reduction in protein levels after just the first dose. This data suggests that PBGENE-HBV could be a powerful treatment for chronic hepatitis B.26789
Who Is on the Research Team?
Stanley Frankel, MD Medical Monitor
Principal Investigator
Precision BioSciences, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with chronic hepatitis B who are not able to have children, have a BMI between 18.0 and 35.0, do not have active hepatitis B e-antigen, and are currently suppressing the virus with nucleoside analogs (NA). They must be in good health as determined by the study investigator and should have documented CHB infection for at least one year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a finite course of multiple IV dose administrations of PBGENE-HBV in a dose escalation and expansion manner
Follow-up
Participants are monitored for safety and effectiveness after treatment, including antiviral activity and safety assessments
What Are the Treatments Tested in This Trial?
Interventions
- PBGENE-HBV
Find a Clinic Near You
Who Is Running the Clinical Trial?
Precision BioSciences, Inc.
Lead Sponsor