BAY81-8973 Pediatric Safety and Efficacy Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any - 12 |
| Updated: | 3/23/2019 |
| Start Date: | June 9, 2011 |
| End Date: | December 31, 2022 |
| Contact: | Bayer Clinical Trials Contact |
| Email: | clinical-trials-contact@bayer.com |
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
The objective of the study is to demonstrate the safety and efficacy of treatment with
BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.
BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.
Inclusion Criteria:
- Male, aged
- Severe hemophilia A defined as < 1% FVIII:C
- PTPs (previously treated patients) > 50 Exposure days (ED) with any high purity FVIII,
or
- PUPs (previously untreated patients) no prior exposure to any high purity FVIII
- MTPs (minimally treated patients) not previously having received more than 3
injections with any FVIII concentrate
- No current evidence or history of inhibitory antibody
Exclusion Criteria:
- History of FVIII inhibitor formation
- Diagnosed with other bleeding disorder
- Platelet count < 100000 cells/μL
- Kidney or liver dysfunction
- Known hypersensitivity to any FVIII
We found this trial at
10
sites
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