Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Congenital FXIII Deficiency

In brief

This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.

Key facts

Study ID

NCT01230021

Run by

Novo Nordisk A/S

People needed

6

Starts

2010-11-01

Expected to finish

2012-01-01

Last updated by the study team

2017-02-24

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent by subject's parents or subject's legally acceptable representative before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
• Age 1 to less than 6 years old at the time of enrolment
• Congenital FXIII subunit-A deficiency previously documented by genotyping or evaluated by genotyping through blood sampling at screening visit
• Body weight at least 10 kg

You may not qualify if…

• Known antibodies to FXIII
• Hereditary or acquired coagulation disorder other than FXIII A-subunit congenital deficiency
• Platelet count (thrombocytes) of less than 50 × 10\^9/L (at screening visit)
• Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus erythematosus
• Previous history of arterial or venous thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis
• Known or suspected allergy to trial product or related products
• Any surgical procedure in the 30 days prior to enrolment and any planned surgery during the trial period
• Any disease or condition which, judged by the Investigator, could imply a potential hazard to the subject or interfere with the trial participation or trial outcome including renal and/or liver dysfunction

Where it is running

• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Detroit, Michigan, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Columbus, Ohio, United States
• Novo Nordisk Investigational Site — Petah Tikva, Israel
• Novo Nordisk Investigational Site — Birmingham, United Kingdom
• Novo Nordisk Investigational Site — Leicester, United Kingdom
• Novo Nordisk Investigational Site — Manchester, United Kingdom
• Novo Nordisk Investigational Site — Newcastle upon Tyne, United Kingdom
• Novo Nordisk Investigational Site — Reading, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.