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Antisense Oligonucleotide

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

Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 weeks
Awards & highlights

B-Well 2 Trial Summary

This trial will test if a new treatment is effective and safe for patients with hepatitis B. It will last up to 102 weeks.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, similar treatments often cause flu-like symptoms (fever, fatigue), injection site reactions (redness or pain), possible liver enzyme elevations indicating liver irritation/inflammation. Participants will be monitored closely for any adverse effects throughout the trial.

B-Well 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants achieving functional cure (FC) with baseline HBsAg ≤3000 IU/mL
Secondary outcome measures
Number of participants achieving FC with baseline HBsAg ≤1000 IU/mL
Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg ≤1000 IU/mL
Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg ≤3000 IU/mL

B-Well 2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BepirovirsenExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,069,916 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,030 Total Patients Enrolled

Media Library

Bepirovirsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05630820 — Phase 3
Chronic Hepatitis B Research Study Groups: Bepirovirsen, Placebo
Chronic Hepatitis B Clinical Trial 2023: Bepirovirsen Highlights & Side Effects. Trial Name: NCT05630820 — Phase 3
Bepirovirsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630820 — Phase 3
Chronic Hepatitis B Patient Testimony for trial: Trial Name: NCT05630820 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor still enrolling participants?

"As per the clinicaltrials.gov database, this research endeavour is actively seeking out willing participants. This project was first broadcasted on December 6th 2022 and recently updated on January 23rd 2023."

Answered by AI

How many volunteers are enrolled in this research project?

"Indeed, according to clinicaltrials.gov, this research trial is actively searching for participants who meet the criteria. The initial posting was on December 6th 2022 and it has most recently been updated on January 23rd 2023; 534 individuals need to be recruited from a single centre."

Answered by AI

Has Bepirovirsen received regulatory endorsement from the FDA?

"Our research indicates that Bepirovirsen has a safety rating of 3, as the Phase 3 trial offers evidence of viability and several reports confirming its security."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
What site did they apply to?
GSK Investigational Site
Other

What questions have other patients asked about this trial?

What should I expect? Is there a placebo group? The project Bepirovirsen HBV treatment when is finished and which step you are in now? Can you share to me the detail timeline of project?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I would like to have a functional cure. I am a CHB patient since 7 years, this cause to me many problems on my health.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
2022. "Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630820.
All > Hepatitis B
~486 spots leftby Jan 2026
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