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

Launched by PRECISION BIOSCIENCES, INC. · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called PBGENE-HBV for adults with chronic hepatitis B, a long-term liver infection. The main goal of the study is to see how safe the treatment is and how well it works to fight the virus. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with chronic hepatitis B for at least a year and are currently on antiviral medication that keeps the virus at low levels. To join, participants should be in good health overall and should not have liver cirrhosis or other serious infections.

If you decide to participate, you'll be closely monitored by healthcare professionals throughout the study. This includes regular check-ups and tests to ensure your safety and to assess how the treatment affects your body. The trial is open to both men and women who meet the specific health criteria, and it aims to provide valuable information that could help improve treatments for chronic hepatitis B in the future.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 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