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Antisense Oligonucleotide

Bepirovirsen for Chronic Hepatitis B (B-Well 1 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
Are you over 18 years old?
Have you been diagnosed with chronic hepatitis B virus infection for at least 6 months?
Must not have
Have you taken any interferon-containing therapy (for example, Pegasys or Peg-Intron) within the past 12 months?
Have you had major surgery within the past 3 months?
Timeline
Screening 60 days
Treatment 24 weeks
Follow Up 48 weeks
Awards & highlights

B-Well 1 Trial Summary

This trial will test if a new treatment can effectively and safely reduce/suppress hepatitis B virus in participants.

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 liver enzymes, and controlled virus levels. They must be willing to potentially stop their usual medication as part of the study. People with cirrhosis, recent cancer (except certain skin cancers), other significant health issues, or co-infections like HIV are not eligible.Check my eligibility
What is being tested?
The trial tests Bepirovirsen's ability to suppress Hepatitis B surface antigen compared to a placebo over 24 weeks. Participants will also continue their standard antiviral drugs during some phases and may stop them in others to assess long-term effects up to approximately 104 weeks.See study design
What are the potential side effects?
Potential side effects of Bepirovirsen aren't detailed here but could include typical drug reactions such as injection site discomfort, flu-like symptoms, fatigue, or more serious immune-related events given its nature as an antiviral agent.

B-Well 1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

B-Well 1 Trial Timeline

Screening ~ 60 days
Treatment ~ 24 weeks
Follow Up ~48 weeks
This trial's timeline: 60 days for screening, 24 weeks for treatment, and 48 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
Does Bepirovirsen help clear the virus substances from the blood, even after treatment stops?
How well does Bepirovirsen work to treat people living with CHB?
Is Bepirovirsen safe to take for up to 24 weeks?

B-Well 1 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
Site NameJohns Hopkins
JH IRB Protocol NumberIRB00361256
Principal InvestigatorMark Sulkowski, MD

Media Library

Bepirovirsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05630807 — Phase 3
Chronic Hepatitis B Clinical Trial 2023: Bepirovirsen Highlights & Side Effects. Trial Name: NCT05630807 — Phase 3
Chronic Hepatitis B Research Study Groups: Bepirovirsen, Placebo
Bepirovirsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630807 — Phase 3

Frequently Asked Questions

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

What is the study drug?

"Bepirovirsen (the study drug) is designed to stop the virus from making substances that we think may prevent the immune system from fighting the virus. By stopping the virus from making those substances, bepirovirsen may potentially allow the body to gain control over the infection."

Answered by AI

What will happen at study visits?

"The study doctor will conduct tests and examinations at study visits to check your hepatitis b virus infection and overall health. Study activities will vary from visit to visit."

Answered by AI

Is Bepirovirsen approved by the FDA?

"Bepirovirsen is not currently approved for use in treating chronic hepatitis b virus infection in the general public. However, it has been given to adults in other clinical studies."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I would like to be cured of HBV, even if it is a functional cure.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
2022. "Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630807.
All > Hepatitis B
~450 spots leftby Oct 2025
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