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NCT Number: NCT01862367

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

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®.

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Key information

Conditions

Congenital Bleeding Disorder Congenital FXIII Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, St. John's, Newfoundland and Labrador, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

catridecacog

Drug

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

Other names: recombinant factor XIII

Primary outcomes

  1. 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

Secondary outcomes

  1. All serious adverse events collected

    Time frame: During study period up to 6 years

  2. All medical events of special interest collected

    Time frame: During study period up to 6 years

  3. All medication errors and near medication errors collected

    Time frame: During study period up to 6 years

  4. 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

  5. Frequency of bleeding episodes collected

    Time frame: During study period up to 6 years

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: mentor™6

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
May 24, 2013
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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