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Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

NCT01220141 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2015-04-16

No results posted yet for this study

Summary

This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B

Interventions

DRUG

activated recombinant human factor VII

Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Argentina
  • Austria
  • Belgium
  • France
  • Germany
  • Hungary
  • Iran
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Slovakia
  • Sweden
  • 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 NCT01220141 on ClinicalTrials.gov