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

July 8, 2019 updated by: Novo Nordisk A/S

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Novo Nordisk Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Novo Nordisk Investigational Site
  • Hungary
      • Debrecen, Hungary, 4012
        • Novo Nordisk Investigational Site
  • Italy
      • Chieti, Italy, 66100
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16147
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29011
        • Novo Nordisk Investigational Site
      • Tortosa, Spain, 43500
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Orange, California, United States, 92868
        • Novo Nordisk Investigational Site
    • Florida
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Novo Nordisk Investigational Site
      • Columbus, Ohio, United States, 43205
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This observational study will enroll patients with congenital FXIII A-subunit deficiency for whom the decision to treat with rFXIII has been made and who are willing to provide informed consent (or patient's legally acceptable representative (LAR) consent, if applicable).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rFXIII
Drug: catridecacog
No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.
Other Names:
  • recombinant factor XIII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: During study period up to 6 years
During study period up to 6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All serious adverse events collected
Time Frame: During study period up to 6 years
During study period up to 6 years
All medical events of special interest collected
Time Frame: During study period up to 6 years
During study period up to 6 years
All medication errors and near medication errors collected
Time Frame: During study period up to 6 years
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
Time Frame: During study period up to 6 years
During study period up to 6 years
Frequency of bleeding episodes collected
Time Frame: During study period up to 6 years
During study period up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2013

Primary Completion (Actual)

June 26, 2019

Study Completion (Actual)

June 26, 2019

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1841-3868
  • U1111-1131-1558 (Other Identifier: WHO)
  • ENCEPP/SDPP/3687 (Registry Identifier: EU PAS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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