Viral Hepatitis
Conditions
Keywords
HDV, Hepatitis D Virus, Hepatitis, Chronic Hepatitis D Virus, Hepatitis D, Hepatitis D, Chronic, Hepatitis Delta Virus, Digestive System Diseases, Liver Diseases
Brief summary
This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide
Interventions
DRUGTobevibart
Tobevibart administered by subcutaneous injection
DRUGElebsiran
Elebsiran administered by subcutaneous injection
DRUGBulevirtide
Bulevirtide administered by subcutaneous injection
Sponsors
Vir Biotechnology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female ages 18 to 70 years at screening 2. HDV RNA ≥ 500 IU/mL at screening 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1 4. Noncirrhotic or compensated cirrhotic liver disease at screening 5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 10 IU/ml at screening, currently on locally approved NRTI therapy
Exclusion criteria
1. Serum ALT ≥ 5 × ULN 2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 3. History of significant liver disease from non-HBV or non-HDV etiology 4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 5. History of anaphylaxis 6. History of immune complex disease 7. History of autoimmune disorder 8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 24 | Week 24 |
| HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) 24 weeks after end of treatment. | 24 Weeks after End of Treatment |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 | Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 |
| HDV RNA < Lower Limit of Quantification (LLOQ), Target not detected (TND) at Week 48, Week 96, Week 120, Week 144, Week 192 and Week 240 | Week 48 , Week 96, Week 120, Week 144, Week 192 and Week 240 |
| Change from baseline in ALT at Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 | Week 24, Week 48, Week 96, Week 120, Week 144, Week 192, and Week 240 |
Countries
Austria, France, Germany, Italy, Romania, Spain, United Kingdom
Outcome results
None listed