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NCT01862367 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

— mentor™6  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01862367
Other study ID # NN1841-3868
Secondary ID U1111-1131-1558E
Status Completed
Phase
First received
Last updated
Start date May 17, 2013
Est. completion date June 26, 2019

Study information
Verified date July 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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®.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 26, 2019
Est. primary completion date June 26, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• catridecacog
No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.

Locations
Country Name City State
Canada Novo Nordisk Investigational Site St. John's Newfoundland and Labrador
Canada Novo Nordisk Investigational Site Toronto Ontario
Hungary Novo Nordisk Investigational Site Debrecen
Italy Novo Nordisk Investigational Site Chieti
Italy Novo Nordisk Investigational Site Genova
Spain Novo Nordisk Investigational Site Barcelona
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Spain Novo Nordisk Investigational Site Tortosa
United Kingdom Novo Nordisk Investigational Site Aberdeen
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Cleveland Ohio
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Detroit Michigan
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site Orange California
United States Novo Nordisk Investigational Site Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Italy,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 All serious adverse events collected During study period up to 6 years
Secondary All medical events of special interest collected During study period up to 6 years
Secondary All medication errors and near medication errors collected During study period up to 6 years
Secondary 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
Secondary Frequency of bleeding episodes collected During study period up to 6 years
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