Long-Term Follow-Up for GSK3228836 in Hepatitis B
(B-Sure Trial)
Recruiting in Palo Alto (17 mi)
+67 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: GlaxoSmithKline
Must be taking: Nucleos(t)ide analogues
Disqualifiers: Other HBV studies, others
No Placebo Group
Prior Safety Data
Trial Summary
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 Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
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
Trial Timeline
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
Treatment Details
Interventions
- GSK3228836 (Virus Therapy)
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: On-NA participantsExperimental Treatment2 Interventions
Participants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Group II: Not-on-NA participantsExperimental Treatment2 Interventions
Participants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Group III: NA-cessated participantsExperimental Treatment2 Interventions
Participants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.
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
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Findings from Research
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.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
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]
References
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]