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COMPLETEDPHASE3

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

A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency. Safety Extension Trial to F13CD-3760

NCT01253811•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

1 - 6 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Completed participation in trial F13CD-3760 (NCT01230021)

Exclusion Criteria

•Known or suspected hypersensitivity to trial product or related products
•Known history of development of inhibitors against FXIII (factor XIII)
•Hereditary or acquired coagulation disorder other than FXIII congenital deficiency
•Platelet count (thrombocytes) less than 50X10e9 / L
•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
•Any disease or condition which, judged by the trial physician, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome including renal and/or liver dysfunction

Locations (4)

Novo Nordisk Clinical Trial Call Center

Boston, Massachusetts, United States

Novo Nordisk Clinical Trial Call Center

Columbus, Ohio, United States

Petah Tikva, Israel

Leicester, United Kingdom

Key Dates

Start Date

January 1, 2011

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

June 24, 2016

Enrollment

ACTUAL participants

Conditions

Congenital Bleeding DisorderCongenital FXIII Deficiency

Interventions

catridecacog

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

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