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Congenital FXIII Deficiency clinical trials

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NCT ID: NCT02670213 Enrolling by invitation - Clinical trials for Congenital Bleeding Disorder

A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

Start date: March 16, 2016
Phase:
Study type: Observational

This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.

NCT ID: NCT01862367 Completed - Clinical trials for Congenital Bleeding Disorder

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

mentor™6
Start date: May 17, 2013
Phase:
Study type: Observational

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®.

NCT ID: NCT01848002 Completed - Healthy Clinical Trials

Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Start date: May 2003
Phase: Phase 1
Study type: Interventional

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

NCT ID: NCT01847989 Completed - Healthy Clinical Trials

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Start date: January 2003
Phase: Phase 1
Study type: Interventional

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

NCT ID: NCT01253811 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

mentor™5
Start date: January 2011
Phase: Phase 3
Study type: Interventional

This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age

NCT ID: NCT01230021 Completed - Clinical trials for Congenital Bleeding Disorder

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

mentor™4
Start date: November 2010
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01082406 Completed - Healthy Clinical Trials

Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

Start date: March 2010
Phase: Phase 1
Study type: Interventional

This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.

NCT ID: NCT00978380 Completed - Clinical trials for Congenital Bleeding Disorder

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

mentor™2
Start date: September 21, 2009
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

NCT ID: NCT00713648 Completed - Clinical trials for Congenital Bleeding Disorder

Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

Start date: August 2008
Phase: Phase 3
Study type: Interventional

The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

NCT ID: NCT00056589 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Start date: March 2003
Phase: Phase 1
Study type: Interventional

This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.