Bepirovirsen for Chronic Hepatitis B
(B-Well 2 Trial)

Recruiting in Palo Alto (17 mi)

+188 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 viral DNA levels in their blood, and normal to slightly elevated liver enzymes. They must not have other infections like HIV or Hepatitis C/D, no recent cancer except certain skin cancers, and can't be on immune-suppressing drugs or have a history of drug abuse.

Inclusion Criteria

I am willing to stop my current NA treatment as required.

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

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

+2 more

Exclusion Criteria

I cannot take immunosuppressive treatments or high doses of steroids.

I have taken interferon therapy in the last 12 months.

I have or might have liver cirrhosis.

+11 more

Participant Groups

The study tests the effectiveness of Bepirovirsen compared to a placebo in suppressing the hepatitis B virus when taken alongside standard antiviral treatment. It's divided into stages including initial double-blind treatment, continued antiviral therapy, potential cessation of antivirals, and monitoring durability of response over approximately two years.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BepirovirsenExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention