A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection

Vir Biotechnology

Status and phase: Enrolling; Phase 3

Conditions: Viral Hepatitis

Treatments: Drug: Elebsiran; Drug: Tobevibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT06903338

VIR-CHDV-V203

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ages 18 to 70 years at screening
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
5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening

Exclusion criteria

1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
2. History of significant liver disease from non-HBV or non-HDV etiology
3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
4. History of anaphylaxis
5. History of immune complex disease
6. History of autoimmune disorder
7. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm 1 (Tobevibart + Elebsiran)

Experimental group

Description:

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

Treatment:

Drug: Tobevibart

Drug: Elebsiran

Arm 2 (Tobevibart + Elebsiran)

Experimental group

Description:

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

Treatment:

Drug: Tobevibart

Drug: Elebsiran