← Back to Search

Antisense Oligonucleotide

Daplusiran/Tomligisiran + Bepirovirsen for Chronic Hepatitis B (B-UNITED Trial)

Phase 2

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 100 weeks

Summary

This trial aims to test the effectiveness and safety of two different doses of a drug combination (DAP/TOM) followed by another drug (bepirovirsen) in people with chronic hepatitis B

Who is the study for?

This trial is for adults over 18 with chronic Hepatitis B who are currently on stable nucleos(t)ide analogue therapy. They must have a specific level of HBsAg and suppressed HBV DNA in their blood, normal liver enzyme levels, and be willing to stop their current treatment as per the study protocol.

What is being tested?

The trial is testing two different doses of Daplusiran/Tomligisiran (DAP/TOM), followed by Bepirovirsen, to see how effective and safe they are for treating chronic Hepatitis B. It also seeks the best dose of DAP/TOM to use before Bepirovirsen in future treatments.

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms, fatigue, headache, abdominal pain or discomfort. The severity can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants achieving functional cure

Secondary study objectives

Number of participants achieving functional cure with high Baseline HBsAg level

Number of participants achieving functional cure with low Baseline HBsAg level

Number of participants achieving functional cure with low Baseline HBsAg level compared against placebo + bepirovirsen arm

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Treatment Arm 2C: Placebo + BepirovirsenExperimental Treatment2 Interventions

Participants with low HBsAg level will receive Placebo in Treatment Stage 1. After Placebo treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.

Group II: Treatment Arm 2B: DAP/TOM + BepirovirsenExperimental Treatment2 Interventions

Participants with low HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.

Group III: Treatment Arm 2A: DAP/TOM + BepirovirsenExperimental Treatment2 Interventions

Participants with low HBsAg level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.

Group IV: Treatment Arm 1B: DAP/TOM + BepirovirsenExperimental Treatment2 Interventions

Participants with high HBsAg level will receive dose level 2 of DAP/TOM in Treatment Stage 1. After DAP/TOM treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.

Group V: Treatment Arm 1A: DAP/TOM + BepirovirsenExperimental Treatment2 Interventions

Participants with high Hepatitis B surface antigen (HBsAg) level will receive dose level 1 of DAP/TOM in Treatment Stage 1. After DAP/TOM Treatment, eligible participants will receive bepirovirsen in Treatment Stage 2. All participants will continue background NA treatment throughout these treatment stages. After bepirovirsen Treatment Stage, participants will be observed during the NA Only Stage, while maintaining background NA treatment. Eligible participants will then discontinue background NA treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Bepirovirsen

2023

Completed Phase 1

~160