NN1841-3868 Use of rFXIII in treatment of congenital FXIII deficiency, a prospective multi-centre observational study (mentor™6)

Study identification

• EU PAS number:
  EUPAS3687
• Study ID:
  36010
• Official title and acronym:
  NN1841-3868 Use of rFXIII in treatment of congenital FXIII deficiency, a prospective multi-centre observational study (mentor™6)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Denmark

  Hungary

  Italy

  Spain

  United Kingdom

  United States
• Study description:
  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®.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novo Nordisk

Multiple centres: 17 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 15/05/2013

Study start date

Actual: 17/05/2013

Date of interim report, if expected

Planned: 30/10/2015

Actual: 09/11/2015

Date of final study report

Planned: 29/06/2020

Actual: 25/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)