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

NCT01862367 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2019-07-09

No results posted yet for this study

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®.

Conditions

  • Congenital Bleeding Disorder
  • Congenital FXIII Deficiency

Interventions

DRUG

catridecacog

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-17
Primary Completion
2019-06-26
Completion
2019-06-26

Countries

  • United States
  • Canada
  • Hungary
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862367 on ClinicalTrials.gov