CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 34 enrolled
Drug / intervention
activated prothrombin complex concentrate (FEIBA)drug
Likely dose
FEIBA 85 U/Kg ±15% three times weekly for prophylaxis or 85 U/Kg ±15% for on-demand bleeding episodesAI-extracted
Key inclusion· 3
  • ✓Hemophilia A of any severity with documented high-titer inhibitor (>5 BU)
  • ✓Currently using bypassing agents (PCCs, aPCCs, or rFVIIa) for treatment of bleeds
  • ✓At least 6 bleeds requiring bypassing therapy in the previous 6 months
Key exclusion· 3
  • ✕Concomitant immune tolerance therapy
  • ✕Clinically symptomatic liver disease
  • ✕Platelet count less than 100,000

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

Search/NCT00221195
NCT00221195Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors

Tulane University School of Medicine·interventional·Posted Sep 22, 2005·Updated Mar 2, 2020

In Brief

A Phase 3 clinical trial evaluating activated prothrombin complex concentrate (FEIBA) for Hemophilia A With Inhibitors. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A With Inhibitors
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJun 1, 2003
Primary CompletionDec 1, 2009
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 20.8 years ago

Interventions

activated prothrombin complex concentrate (FEIBA)drug

FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months