Status:
COMPLETED
Observational Registry of the Treatment of Glanzmann's Thrombasthenia
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Glanzmann's Disease
Eligibility:
All Genders
Brief Summary
This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA). The purpose of the registry is to evaluate the efficacy and safety of activated recombinant hu...
Eligibility Criteria
Inclusion
- Patients with congenital GT defined as patients with lifelong bleeding tendency characterised by impaired or absent platelet aggregation, impaired clot retraction and prolonged bleeding time or prolonged platelet function analyser closure time. The patient has normal platelet counts and platelet morphology. Optional diagnosis criteria are quantitative or qualitative evaluation of GP (Glycoprotein) IIb/IIIa receptor including flow cytometry and identification of gene defects
- Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode or surgical event as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent must be obtained before entry of data into the registry
Exclusion
- Patients with acquired thrombasthenic states caused by autoimmune disorders (acute or chronic) or drugs
Key Trial Info
Start Date :
January 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01476423
Start Date
January 1 2004
End Date
October 1 2011
Last Update
December 23 2014
Active Locations (15)
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1
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
2
Algiers, Algeria, 16035
3
Vienna, Austria, A-1010
4
Brussels, Belgium, 1070