Bepirovirsen Liver Biopsy Study
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational University Health System, Singapore
About this trial
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\<1000 IU/ml
Eligibility criteria
Qualifiers
At least 21 years of age at the time of signing the informed consent.
Documented to be HBsAg positive for ≥ 6 months prior to Screening.
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.
qHBsAg ≤1000 IU/ml
Disqualifiers
qHBsAg > 1000 IU/ml
Do not consent to participate in the Bepirovirsen Liver Biopsy study
Clinically significant abnormalities or clinically significant physical examination findings (e.g. major surgery within 3 months of screening)
Past history of or current co-infection with Hepatitis C infection, Human immunodeficiency virus (HIV) or Hepatitis D virus
Trial design
Treatments tested in this trial
- Bepirovirsen
- Liver biopsy
- Optional Liver biopsy
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
National University Health System, Singapore
Lead sponsor
A*Star
Collaborator
National University of Singapore
Collaborator
Source ClinicalTrials.gov