MedTrace Logo

A Survey on the Success of Inhibitor Elimination Using Individualized Concentrate Selection and Controlled ITI

NCT02207894 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-04-21

No results posted yet for this study

Summary

This research program is initiated to evaluate and document data on the success of ITI in 300 haemophilia A patients with newly developed or already existing FVIII-inhibitors (also patients who might potentially have failed in earlier ITIs), which will be treated with ITI - preferably high-dose based on individualized product selection, in order to improve management of this potentially devastating complication of haemophilia treatment.

In order to investigate the role of in vitro tests on individual ITI success rate in patients undergoing ITI, the inhibitor plasma samples can be assayed against different FVIII concentrates using the following in vitro tests: Batch selection, Thrombin generation assay (TGA), Thrombin Generation Test (TGT) to monitor FVIII efficacy, Epitope mapping,IgG Subclasses specific for FVIII, Immunogenotyping.

Conditions

  • Haemophilia A

Sponsors & Collaborators

  • University of Bonn

    collaborator OTHER

  • Skane University Hospital

    collaborator OTHER

  • Hopital Cardiologique Louis Pradel, Unité d'Hemostase Clinique Bron

    collaborator UNKNOWN

  • Haemophilia Centre Rhine Main

    lead OTHER

Principal Investigators

  • Carmen Escuriola Ettingshausen, MD · Director HZRM

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207894 on ClinicalTrials.gov