Trials / Completed
CompletedNCT04158648
A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors
A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).
Conditions
- Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor
- Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor
- Hemophilia A
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Emicizumab | Four loading doses of emicizumab 3 milligrams per kilogram of body weight (mg/kg) will be administered subcutaneously (SC) once a week (QW) for 4 weeks followed by participant's preference of one of the three following maintenance SC dose regimens: 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W). |
Timeline
- Start date
- 2020-02-10
- Primary completion
- 2021-10-30
- Completion
- 2025-12-19
- First posted
- 2019-11-12
- Last updated
- 2026-01-23
- Results posted
- 2022-12-15
Locations
22 sites across 10 countries: United States, Belgium, Canada, France, Germany, Netherlands, Poland, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04158648. Inclusion in this directory is not an endorsement.