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Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

NCT00697320 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2016-12-07

No results posted yet for this study

Summary

This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

Conditions

  • Congenital Bleeding Disorder
  • Congenital FVII Deficiency
  • Glanzmann's Disease
  • Acquired Bleeding Disorder
  • Acquired Haemophilia

Interventions

DRUG

eptacog alfa (activated)

A NON INTERVENTIONAL OBSERVATIONAL STUDY: Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Germany

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 NCT00697320 on ClinicalTrials.gov