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NCT07696520
Bepirovirsen Liver Biopsy Study
Conditions: HEPATITIS B CHRONIC, Hepatitis B Chronic Infection
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: National University Health System, Singapore
Location: Division of Gastroenterology & Hepatology, National University Hospital (NUH) Singapore
Summary
Bepirovirsen Liver Biopsy study is a single centre open label phase II study to examine the antiviral and immunological effects of bepirovirsen in CHB patients both treated and untreated with HBsAg\
Eligibility Criteria
Inclusion Criteria:
1. At least 21 years of age at the time of signing the informed consent.
2. Documented to be HBsAg positive for ≥ 6 months prior to Screening.
3. Currently receiving stable NA therapy (defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study), or not receiving any Hepatitis B treatment for at least 6 months, or Hepatitis B treatment naïve.
4. qHBsAg ≤1000 IU/ml
5. Alanine aminotransferase (ALT) ≤2x ULN
6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
* Is a woman of non-childbearing potential
* Is a woman of childbearing potential and using a contraceptive method
7. Capable of giving signed informed consent
Exclusion Criteria:
1. qHBsAg \> 1000 IU/ml
2. Do not consent to participate in the Bepirovirsen Liver Biopsy study
3. Clinically significant abnormalities or clinically significant physical examination findings (e.g. major surgery within 3 months of screening)
4. Past history of or current co-infection with Hepatitis C infection, Human immunodeficiency virus (HIV) or Hepatitis D virus
5. History of or liver cirrhosis as determined by:
1. Fibroscan \> 12kPa
2. Participant's historic record of either/both liver biopsy or liver stiffness measurements in their medical records where their results are Liver biopsy Metavir Score is F4, they will be excluded from the study(If the participant has inconsistent clinical picture of cirrhosis, confirm and discuss eligibility with an investigator)
6. Diagnosed with hepatocellular carcinoma as evidenced by Alpha-fetoprotein concentration ≥200 ng/mL or if the screening alpha fetoprotein concentration is ≥50 ng/mL and \
Source: ClinicalTrials.gov (NCT07696520). StuddyBuddy aggregates publicly available trial information.