CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) +1 morebiological
Likely dose
FEIBA NF 85 ± 15 U/kg intravenously every other day (prophylactic arm)AI-extracted
Key inclusion· 9
  • ✓Age 4 to 65 years
  • ✓Hemophilia A or B of any severity with high-titer inhibitor (>5 BU for ≥12 months) or low-titer refractory inhibitor
  • ✓Currently on on-demand treatment for bleeding episodes with bypassing agents (APCC or rFVIIa)
  • ✓At least 12 bleeding episodes requiring bypassing agent treatment in past 12 months
Key exclusion· 10
  • ✕Currently receiving immune tolerance induction (ITI)
  • ✕Currently on regular prophylactic therapy to prevent bleeding episodes
  • ✕Clinically symptomatic liver disease including cirrhosis, portal hypertension, ascites, or PT >5 seconds above ULN
  • ✕Platelet count <100,000/ml

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

Search/NCT00851721
NCT00851721Phase 3Completed
CompareCT.gov

FEIBA NF: A Prospective, Open-label, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Prophylactic Versus On-Demand Treatment in Subjects With Hemophilia A or B and a High Titer Inhibitor

Baxalta now part of Shire·interventional·Posted Feb 26, 2009·Updated May 19, 2021

In Brief

A Phase 3 clinical trial evaluating Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) for Hemophilia A or B With Inhibitors and 2 related conditions. Completed, enrolled 52 participants across 17 sites in 10 countries.

Detailed Summary

The purpose of the study was to determine the efficacy, safety, and health-related quality of life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A or B With Inhibitors, Hemophilia A, Hemophilia B
CountriesBrazil, Bulgaria, Croatia, Japan, New Zealand, Poland, Romania, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2009
Enrollment StartMar 31, 2009
Primary CompletionOct 17, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.3 years ago

Interventions

Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)biological

85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period

Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)biological

FEIBA NF dose and dosing interval as prescribed by the treating physician