A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

Novo Nordisk

Status: Completed

Conditions: Congenital FXIII Deficiency; Congenital Bleeding Disorder

Treatments: Drug: recombinant factor XIII

Study type: Observational

Funder types: Industry

Identifiers

NCT02670213

NN1841-4211

U1111-1162-5426 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.

Enrollment: 8 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment

Trial design

8 participants in 1 patient group

NovoThirteen®

Treatment:

Drug: recombinant factor XIII