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Observational Registry of the Treatment of Glanzmann's Thrombasthenia | Clinical Trials | Clareo Health

COMPLETED

Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Treatment of Glanzmann's Thrombasthenia: A Prospective Observational Registry

NCT01476423•Novo Nordisk A/S

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 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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

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

Locations (15)

Novo Nordisk Clinical Trial Call Center

Princeton, New Jersey, United States

Algiers, Algeria

Vienna, Austria

Brussels, Belgium

Sofia, Bulgaria

Paris La Défense Cedex, France

Mainz, Germany

Budapest, Hungary

Rome, Italy

Alphen aan den Rijn, Netherlands

Key Dates

Start Date

January 1, 2004

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

December 23, 2014

Enrollment

218

ACTUAL participants

Conditions

Congenital Bleeding DisorderGlanzmann's Disease

Interventions

activated recombinant human factor VII

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Observational Registry of the Treatment of Glanzmann's Thrombasthenia

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors