NCT00882778

PROPACT: Retrospective Prophylaxis Patient Case Collection

Prophylactic Treatment With Recombinant Factor VIIa (rFVIIa, NovoSeven®) in Haemophilia Patients With Inhibitors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	eptacog alfa (activated)	Retrospective data collection of the use of activated recombinant human factor VII as prophylaxis in haemophilia patients with inhibitors

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-04-16
• Last updated: 2017-01-09
• Results posted: 2011-07-25

Locations

14 sites across 14 countries: United States, Argentina, Canada, Croatia, Czechia, France, Germany, Ireland, Italy, Slovakia, Spain, Sweden, Switzerland, United Kingdom