PROPACT: Retrospective Prophylaxis Patient Case Collection

Completed

Conditions studied: Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

In brief

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.

Key facts

Study ID

NCT00882778

Run by

Novo Nordisk A/S

People needed

86

Starts

2009-04-01

Expected to finish

2010-05-01

Last updated by the study team

2017-01-09

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Haemophilia A or B with inhibitors
• Prescribed use of activated recombinant human factor VII for any type of prophylaxis with a duration of at least 30 days

You may not qualify if…

• Prophylaxis prescribed post-surgery
• One or more coagulation disorders in addition to haemophilia

Where it is running

• Novo Nordisk Investigational Site — Princeton, New Jersey, United States
• Novo Nordisk Investigational Site — Prov. de Buenos Aires, Argentina
• Novo Nordisk Investigational Site — Mississauga, Canada
• Novo Nordisk Investigational Site — Zagreb, Croatia
• Novo Nordisk Investigational Site — Prague, Czechia
• Novo Nordisk Investigational Site — Paris La Défense Cedex, France
• Novo Nordisk Investigational Site — Mainz, Germany
• Novo Nordisk Investigational Site — Dublin, Ireland
• Novo Nordisk Investigational Site — Rome, Italy
• Novo Nordisk Investigational Site — Bratislava, Slovakia
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Malmö, Sweden
• Novo Nordisk Investigational Site — Zurich, Switzerland
• Novo Nordisk Investigational Site — Crawley, United Kingdom

Full record on ClinicalTrials.gov

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