Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Completed

Conditions studied: Congenital Bleeding Disorder, Glanzmann's Disease

In brief

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 human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.

Key facts

Study ID

NCT01476423

Run by

Novo Nordisk A/S

People needed

218

Starts

2004-01-01

Expected to finish

2011-10-01

Last updated by the study team

2014-12-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with acquired thrombasthenic states caused by autoimmune disorders (acute or chronic) or drugs

Where it is running

• Novo Nordisk Clinical Trial Call Center — Princeton, New Jersey, United States
• Study site — Algiers, Algeria
• Study site — Vienna, Austria
• Study site — Brussels, Belgium
• Study site — Sofia, Bulgaria
• Study site — Paris La Défense Cedex, France
• Study site — Mainz, Germany
• Study site — Budapest, Hungary
• Study site — Rome, Italy
• Study site — Alphen aan den Rijn, Netherlands
• Study site — Karachi, Pakistan
• Study site — Madrid, Spain
• Study site — Malmö, Sweden
• Study site — Zurich, Switzerland
• Study site — Crawley, United Kingdom

Full record on ClinicalTrials.gov

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