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PROPACT: Retrospective Prophylaxis Patient Case Collection

NCT00882778 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2017-01-09

Study results available
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Summary

This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors

Interventions

DRUG

eptacog alfa (activated)

Retrospective data collection of the use of activated recombinant human factor VII as prophylaxis in haemophilia patients with inhibitors

Sponsors & Collaborators

Principal Investigators

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

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Argentina
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Ireland
  • Italy
  • Slovakia
  • 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 NCT00882778 on ClinicalTrials.gov