CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
rFVIIIFcbiological
Likely dose
rFVIIIFc 200 IU/kg/day during ITI period; 50 or 100 IU/kg during tapering period; prophylactic regimen in follow-up period, administered intravenouslyAI-extracted
Key inclusion· 3
  • ✓Male of any age with severe hemophilia A confirmed from medical record
  • ✓High-titer inhibitors with historical peak ≥5 Bethesda units per milliliter (BU/mL)
  • ✓Prior treatment with plasma-derived or recombinant conventional or Extended Half-Life FVIII
Key exclusion· 6
  • ✕Other coagulation disorders in addition to hemophilia A
  • ✕Previous immune tolerance induction (ITI)
  • ✕History of hypersensitivity or anaphylaxis with any FVIII administration
  • ✕Planned major surgery during the study unless deferred until after completion

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03093480
NCT03093480Phase 4Completed
CompareCT.gov

A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects With Inhibitors Undergoing the First ITI Treatment

Bioverativ, a Sanofi company·interventional·Posted Mar 28, 2017·Updated Mar 28, 2022

In Brief

A Phase 4 clinical trial evaluating rFVIIIFc for Hemophilia A With Inhibitors. Completed, enrolled 16 participants across 37 sites in 10 countries.

Detailed Summary

The primary purpose of this study was to describe the time to tolerization (i.e., ITI success) with rFVIIIFc in participants within a maximum of 48 weeks (12 months) of ITI treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A With Inhibitors
CountriesBelgium, Bulgaria, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, United States
CollaboratorsSwedish Orphan Biovitrum

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 28, 2017
Enrollment StartDec 8, 2017
Primary CompletionMay 4, 2020
Study CompletionFeb 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.3 years ago

Interventions

rFVIIIFcbiological

rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously.