A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide
Recruiting
Phase 3
Interventional Study
Viral Hepatitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Vir Biotechnology, Inc. · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 h…
Contacts