Clinical Trial

Disease: Chronic Hepatitis B, HBV, (NCT06680232)

Disease info:

Chronic hepatitis B is an inflamed state of the liver that is caused by infection with hepatitis B virus (HBV). HBV can cause both an acute (short-term) or chronic (long-term) infection. The virus spreads through contact with blood, semen and other body fluids from a HBV-infected person. The inflammation causes damage to the liver and in rare cases it can cause liver failure. Long term, it can also cause cirrhosis (scarring of the liver) and liver cancer. The virus integrates its DNA into the host genome, and thus, may remain latent for several years until reactivation. 

The symptoms of acute hepatitis B include yellowing of skin and eyes, dark yellow urine, diarrhoea, fever, fatigue, nausea, joint- and abdominal pain. In chronic hepatitis B, the symptoms may not show until years after the infection has taken place, after which treatment is needed. 

Treatment of chronic hepatitis B includes oral antiviral agents such as tenofovir or entecavir. These medications selectively inhibit the viral reverse transcriptase, a crucial enzyme that the virus needs to replicate itself. 

Frequency:
WHO estimates that a total of 296 million people worldwide are living with chronic hepatitis B, with 1.5 million new infections each year. The frequencies vary a lot from area to area, but is most common in Eastern Asia and Africa.
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)
Who:

Contact

Phone: 800-371-8953

Email: ELIMINATE-B@precisionbiosciences.com

Partners:
Locations:

Republic of Moldova

ICS ARENSIA Exploratory Medicine SRL, Chisinau, Moldova, Republic of Moldova, 2025

Study start:
Nov. 1, 2024
Enrollment:
45 participants
Gene editing method:
ARCUS Genome Editing
Type of edit:
Gene disruption
Gene:
Hepatitis B virus genome
Delivery method:
Lipid nanoparticles - In-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

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.

Last updated: Nov. 19, 2024
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