NCT01779921

Treatment of Congenital Factor VII Deficiency

Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Bleeding Disorder
• Congenital FVII Deficiency

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
DRUG	Fresh frozen plasma (Source unspecified)	Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
DRUG	Plasma-derived FVII (LFB)	Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
DRUG	Prothrombin Complex conc. (PCC)	Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
DRUG	Plasma-derived FVII conc. (pdFVII Baxter)	Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
DRUG	Plasma-derived FVII conc. (pdFVII PFL)	Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Timeline

• Start date: 2005-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2013-01-30
• Last updated: 2017-01-12

Locations

16 sites across 16 countries: United States, France, Germany, Greece, Hong Kong, India, Iran, Israel, Italy, Pakistan, Serbia, Slovakia, Spain, Thailand, Turkey (Türkiye), Venezuela