What the trial was testing
The B-Clear enrolled 457 patients with hepatitis b. The study was sponsored by GlaxoSmithKline and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
9-10% achieved sustained surface antigen loss after 24 weeks of treatment.
New England Journal of Medicine · 2022 · NCT04449029
These findings — that achieved sustained loss of hepatitis B surface antigen — a marker of functional cure — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 457 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with hepatitis b, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Bepirovirsen is still in development and not yet FDA-approved. A larger Phase 3 program is underway. Standard chronic hepatitis B treatment with daily entecavir or tenofovir is FDA-approved and effective at suppressing the virus. Ask a liver specialist about approved options or open trials.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open hepatitis b trials
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001, and will be conducted in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV). Part B: MAD study in approximately 30 adult participants living with Chronic Hepatitis B (CHB).