Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

Novo Nordisk

Status: Completed

Conditions: Congenital Bleeding Disorder; Congenital FVII Deficiency

Treatments: Drug: activated recombinant human factor VII

Study type: Observational

Funder types: Industry

Identifiers

NCT01312636

F7HAEM-3862

U1111-1116-1529 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Congenital FVII deficiency
• Never been treated with NovoSeven® before
• Patients already in treatment with NovoSeven®

Exclusion criteria

• History of hypersensitivity to any of the components in NovoSeven®

Trial design

36 participants in 1 patient group

A

Treatment:

Drug: activated recombinant human factor VII