At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 16 enrolled
Drug / intervention
Recombinant coagulation factor (rFVIIIFc)biological
Likely dose
Recombinant coagulation factor (rFVIIIFc) 200 IUfrom 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 Non-Controlled, Open-Label, Multicenter, Study of Immune Tolerance Induction Performed With rFVIIIFc Within a Timeframe of 60 Weeks in Severe Haemophilia A Patients With Inhibitors Who Have Failed Previous Immune Tolerance Induction Therapies
In Brief
A Phase 4 clinical trial evaluating Recombinant coagulation factor (rFVIIIFc) for Hemophilia A. Completed, enrolled 16 participants across 12 sites in 7 countries.
Detailed Summary
The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at tolerization.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A
CountriesCanada, Germany, Ireland, Slovenia, Sweden, United Kingdom, United States
CollaboratorsBioverativ Therapeutics Inc.
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartAug 2017
Primary CompletionSep 2019
Study CompletionAug 2020
TodayJul 2026
First PostedApr 6, 2017
Enrollment StartAug 29, 2017
Primary CompletionSep 4, 2019
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.2 years ago
Interventions
Recombinant coagulation factor (rFVIIIFc)biological
rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement administered intravenously.