Trials / Completed
CompletedNCT02795767
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors
A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Emicizumab | Emicizumab will be administered as per the schedule specified in the respective arm. |
Timeline
- Start date
- 2016-07-22
- Primary completion
- 2018-04-30
- Completion
- 2020-11-11
- First posted
- 2016-06-10
- Last updated
- 2021-06-02
- Results posted
- 2019-04-10
Locations
28 sites across 10 countries: United States, Costa Rica, France, Germany, Italy, Japan, South Africa, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02795767. Inclusion in this directory is not an endorsement.