drugset / Trial / NCT06907290
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
Timeline
- Start
- 2025-03-25
- Primary completion
- 2029-05
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brelovitug | Unknown | 300 mg | Subcutaneous |
| Subject | Brelovitug | Unknown | 900 mg | Subcutaneous |