Status:
TERMINATED
Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development
Lead Sponsor:
CSL Behring
Conditions:
Hemophilia A
Eligibility:
MALE
28-11 years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- Male subjects diagnosed with haemophilia A (≤ 2% FVIII level in the absence of factor replacement, according to their medical history).
- Age 28 days to \<12 years.
- Subject is eligible for immune tolerance induction (ITI) therapy
Exclusion
- The subject has received ITI previously.
- Subjects with a historical peak inhibitor titre of ≥ 200 BU/mL.
- Concomitant treatment with drugs with immunosuppressive side effects (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin or the use of a protein A column or plasmapheresis and interferons.
- High risk of cardiovascular, cerebrovascular, or other thromboembolic events (excluding catheter thrombosis) as judged by the investigator.
- Subjects who are human immunodeficiency virus (HIV)-1 or HIV-2 positive (as reported in the medical records or determined at screening).
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01445197
Start Date
December 1 2012
End Date
December 1 2013
Last Update
October 3 2017
Active Locations (7)
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1
Study Site
Vienna, Austria
2
Study Site
Frankfurt, Germany
3
Study Site
Hamburg, Germany
4
Study Site
Athens, Greece