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Observational Registry of the Treatment of Glanzmann's Thrombasthenia

NCT01476423 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 218

Last updated 2014-12-23

No results posted yet for this study

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.

Conditions

  • Congenital Bleeding Disorder
  • Glanzmann's Disease

Interventions

DRUG

activated recombinant human factor VII

A prospective, observational multi-national registry collecting data and evaluating the efficacy and safety of rFVIIa in patients with GT with past or present refractoriness to platelet transfusions. The registry will also collect data from a broader range of GT patients treated with systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) used in the clinics. Data collection will continue for a maximum of six years. Baseline data as well as data obtained during either bleeding episodes or invasive procedures/surgeries will be recorded in the registry.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Algeria
  • Austria
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Pakistan
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01476423 on ClinicalTrials.gov