NCT01445197

Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to Evaluate Plasma-Derived Antihaemophilic Factor/Von Willebrand Factor Concentrate (Biostate®) for Immune Tolerance Induction in Male Paediatric Subjects With Haemophilia A (≤ 2%) Who Have Developed High-titre Antibodies to Factor VIII (Factor VIII Inhibitors)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 28 Days – 11 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tolerance therapy.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Biostate	200 IU/kg administered daily

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-10-03
• Last updated: 2017-10-03

Locations

7 sites across 5 countries: Austria, Germany, Greece, Italy, Russia