Trials / Recruiting
RecruitingNCT07416604
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | NXT007 | NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product. |
| DRUG | Emicizumab | Emicizumab will be administered subcutaneously (SC) using vial and syringe. |
Timeline
- Start date
- 2026-04-30
- Primary completion
- 2028-02-29
- Completion
- 2032-01-29
- First posted
- 2026-02-18
- Last updated
- 2026-04-07
Locations
3 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07416604. Inclusion in this directory is not an endorsement.