Tobevibart + Elebsiran for Hepatitis

Recruiting at 7 trial locations

Overseen By Study Inquiry

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vir Biotechnology, Inc.

Must be taking: NRTI therapy

Disqualifiers: Liver disease, Autoimmune disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 240 weeks

120 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on NRTI therapy for HBV or have low HBV DNA levels to participate.

What is the purpose of this trial?

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.

Eligibility Criteria

This trial is for individuals with chronic hepatitis delta virus (HDV) infection. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of HDV.

Inclusion Criteria

2. Chronic HDV infection for \>/= 6 months

3. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 20 IU/ml at screening, currently on locally approved NRTI therapy

4. Serum ALT \> ULN and \< 5x ULN

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Participants are observed before starting treatment

Duration not specified

Treatment

Participants receive tobevibart + elebsiran for 240 weeks

240 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Elebsiran
• Tobevibart

Trial Overview The study is testing the effectiveness and safety of combining two drugs, Tobevibart and Elebsiran, in treating chronic HDV infection. It's an open-label, randomized Phase 3 trial comparing immediate treatment with these drugs versus delayed treatment.

Participant Groups

Group I: Arm 2 (Tobevibart + Elebsiran) Experimental Treatment 2 Interventions

Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.

Group II: Arm 1 (Tobevibart + Elebsiran) Experimental Treatment 2 Interventions

Participants will receive treatment with tobevibart + elebsiran for 240 weeks.

Who Is Running the Clinical Trial?

Vir Biotechnology, Inc.

Lead Sponsor

Trials

30

Recruited

13,300+