Bepirovirsen for Chronic Hepatitis B
(B-Well 1 Trial)

Recruiting in Palo Alto (17 mi)

+149 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing bepirovirsen, a medication that aims to lower a key protein made by the hepatitis B virus. Bepirovirsen has shown reductions in viral components in cell culture and animal models. It targets patients with specific levels of this protein in their blood. The goal is to see if bepirovirsen can better control the infection compared to current treatments.

Eligibility Criteria

This trial is for adults with chronic Hepatitis B who've been on stable antiviral therapy for at least 6 months, have low liver enzymes, and controlled virus levels. They must be willing to potentially stop their usual medication as part of the study. People with cirrhosis, recent cancer (except certain skin cancers), other significant health issues, or co-infections like HIV are not eligible.

Inclusion Criteria

Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN).

Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.

Plasma or serum HBsAg concentration >100 IU/mL, but no greater than ≤3000 IU/mL.

+3 more

Exclusion Criteria

Have you taken any interferon-containing therapy (for example, Pegasys or Peg-Intron) within the past 12 months?

You have been diagnosed with Liver Disease

Have you had major surgery within the past 3 months?

+12 more

Participant Groups

The trial tests Bepirovirsen's ability to suppress Hepatitis B surface antigen compared to a placebo over 24 weeks. Participants will also continue their standard antiviral drugs during some phases and may stop them in others to assess long-term effects up to approximately 104 weeks.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BepirovirsenExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention