drugset / Trial / NCT07416604
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.
Timeline
- Start
- 2026-04-27
- Primary completion
- 2028-02-29
- Completion
- 2032-01-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Emicizumab | Monoclonal antibody | 1.5 mg/kg | Subcutaneous |
| Comparator | Emicizumab | Monoclonal antibody | 3 mg/kg | Subcutaneous |
| Comparator | Emicizumab | Monoclonal antibody | 6 mg/kg | Subcutaneous |
| Subject | NXT007 | Unknown | — | Subcutaneous |