International Immune Tolerance Study

Status Terminated

Clinical Trial Summary

The purpose of this study is to see if a low-dose arm or a high dose-arm of immune tolerance is more effective in eliminating inhibitors in patients with hemophilia A.

Clinical Trial Description

Subjects will be randomized into a low-dose or high-dose immune tolerance regimen and this study will compare the success rates, the time to achieve tolerance,the complications and the cost of both regimens.It will also aim to identify predictors of successful immune tolerance. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00212472
Study type	Interventional
Source	New York Presbyterian Hospital
Contact
Status	Terminated
Phase	N/A
Start date	July 2002
Completion date	December 2012

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See also
Status	Clinical Trial	Phase
Completed	`NCT00231751` - The Malmö International Brother Study (MIBS)	N/A
Completed	`NCT00221195` - Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors	Phase 2/Phase 3
Terminated	`NCT02484638` - Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors	Phase 2/Phase 3
Withdrawn	`NCT03002480` - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography	N/A
Completed	`NCT03093480` - A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)	Phase 4
Completed	`NCT02448680` - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa	Phase 3
Active, not recruiting	`NCT01105546` - rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors	Phase 2
Completed	`NCT02020369` - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX	Phase 3