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Subcutaneous Bepirovirsen for Hepatitis B

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Prior treatment with any oligonucleotide or small interfering ribonucleoside (RNA) siRNA within 12 months before dosing.
Loss of blood or blood products in excess of 500 millilitre (mL) within any 3-month period during the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 64
Awards & highlights

Summary

This trial tests how well a medication called bepirovirsen is absorbed when injected under the skin using either a traditional vial or a prefilled syringe with a safety feature. Healthy adults are participating to see if both methods are equally effective and safe, and to check if people can safely inject themselves using the prefilled syringe.

Who is the study for?
Healthy adults who can consent to study requirements are eligible for this trial. They must have normal medical evaluations, including lab tests and vital signs, and not be enrolled in other studies. Exclusions include abnormal blood pressure, positive tests for HBV, HCV or HIV, recent COVID-19 symptoms or infection, use of certain medications including immunosuppressives and oligonucleotides, significant blood loss recently, drug abuse history or regular alcohol consumption.
What is being tested?
The study is testing the bioavailability (how well the body absorbs) of Bepirovirsen when delivered from a vial versus a prefilled syringe with safety device in healthy participants. It will also evaluate self-administration using the prefilled syringe and monitor the safety and tolerability of Bepirovirsen.
What are the potential side effects?
While specific side effects are not listed here for Bepirovirsen as it's being tested on healthy individuals primarily for absorption rates rather than treatment efficacy at this stage; generally such trials look out for any adverse reactions ranging from local site reactions to systemic effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had treatments with oligonucleotide or siRNA in the last year.
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I have not lost more than 500 mL of blood in the last 3 months.
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I have not been exposed to more than 4 new drugs in the last year.
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I have not shown COVID-19 symptoms or tested positive for it in the last 14 days.
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I do not regularly use drugs, including THC.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 64 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants
Secondary study objectives
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 4 Participants
Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.
Group II: Group 3Experimental Treatment1 Intervention
Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.
Group III: Group 2Experimental Treatment1 Intervention
Participants will receive Bepirovirsen PFS SSD administered by HCP.
Group IV: Group 1Experimental Treatment1 Intervention
Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bepirovirsen
2023
Completed Phase 1
~160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Hepatitis B include nucleos(t)ide analogs, pegylated interferons, and antisense oligonucleotides. Nucleos(t)ide analogs, such as entecavir and tenofovir, inhibit the viral polymerase enzyme, preventing the virus from replicating its DNA. Pegylated interferons boost the immune system's response to the virus, helping to clear infected cells. Antisense oligonucleotides, like bepirovirsen, bind to viral RNA, blocking its translation and leading to the degradation of viral RNA. These treatments are crucial for Hepatitis B patients as they reduce viral load, decrease liver inflammation, and lower the risk of liver damage and hepatocellular carcinoma.
In vivo reduction of hepatitis B virus antigenemia and viremia by antisense oligonucleotides.[Inhibition of hepatitis B virus by combined siRNAs in vitro].

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,647 Total Patients Enrolled
168 Trials studying Hepatitis B
340,619 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,854 Total Patients Enrolled
130 Trials studying Hepatitis B
333,174 Patients Enrolled for Hepatitis B
~83 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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