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Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

NCT00713648•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit)
•Treatment with regular FXIII replacement therapy initiated at least 6 months prior to screening and one of the following : a documented history of at least one 1 treatment-requiring bleeding episode prior to initiation of regular replacement therapy or a documented family history of FXIII congenital deficiency (only for subjects on regular replacement therapy prior to screening)
•Documented history of at least two 2 bleeding episodes requiring treatment with FXIII containing blood products within the last 12 months prior to screening (only for subjects receiving on-demand treatment prior to screening)

Exclusion Criteria

•Known neutralizing antibodies (inhibitors) towards FXIII
•Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
•Documented history of at least 2 treatment-requiring bleeding episodes per year during previous regular replacement therapy with FXIII containing blood products (fresh frozen plasma (FFP), plasma-derived FXIII (pd FXIII) and cryoprecipitate)
•Known or suspected allergy to trial product(s) or related products
•Planned major surgery during the trial period. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
•Renal insufficiency defined as current dialysis therapy
•Any history of confirmed venous or arterial thrombo-embolic events

Locations (35)

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Orange, California, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Novo Nordisk Investigational Site

Detroit, Michigan, United States

Novo Nordisk Investigational Site

East Lansing, Michigan, United States

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Novo Nordisk Investigational Site

Columbus, Ohio, United States

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

April 1, 2010

Completion Date

April 1, 2010

Last Updated

February 24, 2017

Enrollment

41

ACTUAL participants

Conditions

Congenital Bleeding DisorderCongenital FXIII Deficiency

Interventions

catridecacog

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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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: February 24, 2017Data 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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