Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

Completed

• Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency
• Interventions: Drug: catridecacog

• Registration Number: NCT01862367
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rFXIII	catridecacog	-

Primary Outcome Measures

Name	Time	Method
Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with rFXIII,comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of effect collected	During study period up to 6 years

Secondary Outcome Measures

Name	Time	Method
All serious adverse events collected	During study period up to 6 years
All medical events of special interest collected	During study period up to 6 years
All medication errors and near medication errors collected	During study period up to 6 years
Use of rFXIII in patients with congenital FXIII A-subunit deficiency also for other uses than for prophylactic treatment collected	During study period up to 6 years
Frequency of bleeding episodes collected	During study period up to 6 years

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Aberdeen, United Kingdom