450 Participants Needed

Long-Term Follow-Up for GSK3228836 in Hepatitis B

(B-Sure Trial)

Recruiting at 67 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: GlaxoSmithKline
Must be taking: Nucleos(t)ide analogues
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is checking the duration of benefits for people who previously took the medication GSK3228836 and showed improvement. No new treatment will be given during this study.

Will I have to stop taking my current medications?

If you are currently on a stable nucleos(t)ide analogue (NA) treatment, you will need to stop taking it according to the study's cessation schedule. If you are not on NA treatment, you do not need to stop any current medications.

What data supports the effectiveness of the drug GSK3228836 (Bepirovirsen) in treating chronic hepatitis B?

Research shows that Bepirovirsen, an antisense oligonucleotide, significantly reduces hepatitis B surface antigen levels in patients with chronic hepatitis B, especially in those who are treatment-naïve. It has a favorable safety profile, with most side effects being mild or moderate.12345

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for people who have had Hepatitis B and were previously treated with GSK3228836, achieving full or partial virus control. They must be able to stop their current antiviral meds as per the study's schedule and give informed consent. Those in other HBV studies or with conditions that make participation risky can't join.

Inclusion Criteria

I've had a successful treatment with GSK3228836 for hepatitis B.
I am able to understand and sign the consent form.
I have had GSK3228836 before and it partially worked for me.
See 1 more

Exclusion Criteria

Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836
Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Follow-up

Participants are monitored for durability of treatment response from the parent study

33 months

Extended Follow-up

Participants maintaining functional cure or partial response are followed up for an additional 2 years

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • GSK3228836
Trial Overview The study isn't testing a new treatment; instead, it's checking how long the effects of GSK3228836 last in patients who've already taken it. It looks at whether they maintain low levels of hepatitis B surface antigen (HBsAg) and DNA without further doses.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: On-NA participantsExperimental Treatment2 Interventions
Group II: Not-on-NA participantsExperimental Treatment2 Interventions
Group III: NA-cessated participantsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

Bepirovirsen, an antisense oligonucleotide, showed promising results in reducing hepatitis B surface antigen (HBsAg) levels with a favorable safety profile after just 4 weeks of treatment in patients with chronic hepatitis B virus (HBV) infection.
The phase 2b B-Clear study enrolled 457 participants and aims to evaluate the long-term efficacy of bepirovirsen in achieving HBsAg and HBV DNA seroclearance after treatment, comparing results in patients receiving nucleos(t)ide analog therapy versus those not on therapy.
B-Clear Phase 2b Study Design: Establishing the Efficacy and Safety of Bepirovirsen in Patients with Chronic Hepatitis B Virus Infection.Cremer, J., Elston, R., Campbell, FM., et al.[2023]
In a phase 2b trial involving 457 participants with chronic hepatitis B virus (HBV) infection, bepirovirsen treatment led to sustained loss of hepatitis B surface antigen (HBsAg) and HBV DNA in 9-10% of participants, indicating its potential efficacy as a treatment.
While bepirovirsen showed some effectiveness, it was associated with more adverse events, such as injection-site reactions and fatigue, compared to placebo, highlighting the need for further studies to evaluate its safety and long-term effects.
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection.Yuen, MF., Lim, SG., Plesniak, R., et al.[2023]
GSK3389404, an investigational treatment for chronic hepatitis B virus (HBV) infection, demonstrated a dose-dependent reduction in hepatitis B surface antigen (HBsAg), indicating its potential to target HBV RNA and reduce viral protein production.
The study, involving 66 patients, showed that while GSK3389404 had an acceptable safety profile with no deaths reported, no effective dosing regimen was identified, as no patients achieved HBsAg seroclearance.
Phase IIa, randomised, double-blind study of GSK3389404 in patients with chronic hepatitis B on stable nucleos(t)ide therapy.Yuen, MF., Heo, J., Kumada, H., et al.[2023]

Citations

B-Clear Phase 2b Study Design: Establishing the Efficacy and Safety of Bepirovirsen in Patients with Chronic Hepatitis B Virus Infection. [2023]
Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. [2023]
Phase IIa, randomised, double-blind study of GSK3389404 in patients with chronic hepatitis B on stable nucleos(t)ide therapy. [2023]
Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial. [2022]
Progress in the treatment of chronic hepatitis B: long-term experience with adefovir dipivoxil. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security