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BAY81-8973 Pediatric Safety and Efficacy Trial

Haemophilia A Clinical Trial

Official title:
A Multicenter Phase III Uncontrolled Open-label Trial to Evaluate Safety and Efficacy of BAY81-8973 in Children With Severe Hemophilia A Under Prophylaxis Therapy

Clinical Trial Summary

The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A. The secondary objectives were - To assess the safety and efficacy of BAY81-8973 during surgeries. - To assess incremental recovery of BAY81-8973. - To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated patients [PTPs] and previously untreated patients [PUPs] / minimally treated patients [MTPs] - participation in PK sampling was voluntary and required consent).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01311648
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 3
Start date June 9, 2011
Completion date October 27, 2020
View Details
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