Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study (mentor™6)

Novo Nordisk

Status: Completed

Conditions: Congenital FXIII Deficiency; Congenital Bleeding Disorder

Treatments: Drug: catridecacog

Study type: Observational

Funder types: Industry

Identifiers

NCT01862367

U1111-1131-1558 (Other Identifier)

NN1841-3868

ENCEPP/SDPP/3687 (Registry Identifier)

Details and patient eligibility

About

This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect.

The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
• Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
• Congenital FXIII A-subunit deficiency
• Actual or planned exposure to rFXIII

Trial design

30 participants in 1 patient group

rFXIII

Treatment:

Drug: catridecacog