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Bepirovirsen Liver Biopsy Study

ConditionsHEPATITIS B CHRONICHepatitis B Chronic Infection
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Bepirovirsen

    Drug

    Weekly Bepirovirsen treatment for 24 weeks, with loading doses

  • Liver biopsy

    Procedure/Surgery

    Liver biopsy as previously described

  • Optional Liver biopsy

    Procedure/Surgery

    An optional Liver biopsy as previously described

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Participants on Nucleoside Analogue treatmentExperimental treatment 3 interventions
Group B: Participants not on Nucleoside Analogue treatmentExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Functional cure rate after 24 weeks of weekly Bepirovirsen therapy at the end of the study at 72 weeks and 60 weeks for participants on NA therapy and not on NA therapy respectively.

Functional cure defined as HBsAg\<0.05 IU/ml and HBV DNA \<LLOQ 24 weeks off all therapy

Time frame
72 weeks

Secondary outcomes

1

Changes in intrahepatic virology

The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;

Time frame
Up to week 72
2

Changes in Intrahepatic immunology

The changes in the liver immune cells compared to baseline

Time frame
Up to week 72
3

Changes in blood biomarkers

The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBsAg isoforrms, ultrasensitive HBsAg compared to baseline; changes in immune cell phenotypes, blood cytokines compared to baseline

Time frame
Up to week 72
4

Safety measurements including adverse events (AEs) and serious adverse events (SAEs)

Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant adverse events of interest

Time frame
Up to week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University Health System, Singapore

Lead sponsor

A*Star

Collaborator

National University of Singapore

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: