Treatment of Congenital Factor VII Deficiency

Completed

Conditions studied: Congenital Bleeding Disorder, Congenital FVII Deficiency

In brief

This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis. Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

Key facts

Study ID

NCT01779921

Run by

Novo Nordisk A/S

People needed

163

Starts

2005-10-01

Expected to finish

2012-01-01

Last updated by the study team

2017-01-12

Who can join

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

You may qualify if…

• Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode, surgical event or prophylactic regimen as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent should preferentially be obtained before initiation of treatment or as a minimum before entry of data into the database
• Any patient with a FVII deficiency for whom treatment of bleeding episodes, prevention related to surgery and primary/secondary prophylaxis is considered necessary by the treating physician can be enrolled
• Patients with FVII deficiency without any immediate need for treatment will be entered as stand by registered patients with capture of baseline- and demographic data only. Admission data is entered once an event occurs

Where it is running

• Novo Nordisk Investigational Site — Princeton, New Jersey, United States
• Novo Nordisk Investigational Site — Paris La Défense Cedex, France
• Novo Nordisk Investigational Site — Mainz, Germany
• Novo Nordisk Investigational Site — Vouliagment, Greece
• Novo Nordisk Investigational Site — Kowloon, Hong Kong
• Novo Nordisk Investigational Site — Bangalore, India
• Novo Nordisk Investigational Site — Tehran, Iran
• Novo Nordisk Investigational Site — Kfar Saba, Israel
• Novo Nordisk Investigational Site — Rome, Italy
• Novo Nordisk Investigational Site — Karachi, Pakistan
• Novo Nordisk Investigational Site — Belgrade, Serbia
• Novo Nordisk Investigational Site — Bratislava, Slovakia
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Bangkok, Thailand
• Novo Nordisk Investigational Site — Istanbul, Turkey (Türkiye)
• Novo Nordisk Investigational Site — Caracas, Venezuela

Full record on ClinicalTrials.gov

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