At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 88 enrolled
Drug / intervention
Emicizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Emicizumab for Hemophilia A. Completed, enrolled 88 participants across 28 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesCosta Rica, France, Germany, Italy, Japan, South Africa, Spain, Turkey (Türkiye), United Kingdom, United States
CollaboratorsChugai Pharmaceutical
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJul 2016
Primary CompletionApr 2018
Study CompletionNov 2020
TodayJul 2026
First PostedJun 10, 2016
Enrollment StartJul 22, 2016
Primary CompletionApr 30, 2018
Study CompletionNov 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.1 years ago
Interventions
Emicizumabdrug
Emicizumab will be administered as per the schedule specified in the respective arm.