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Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 (mentor™2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00978380
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : December 13, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Congenital FXIII Deficiency Drug: catridecacog Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency
Actual Study Start Date : September 21, 2009
Actual Primary Completion Date : October 20, 2015
Actual Study Completion Date : October 20, 2015


Arm Intervention/treatment
Experimental: A Drug: catridecacog
Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)
Other Name: recombinant factor XIII




Primary Outcome Measures :
  1. Adverse Events (AEs)(Serious and Non-serious) [ Time Frame: All AEs were collected and reported from screening (week 0) for a minimum period of 52 weeks or until the end of trial visit. ]
    An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Trial AEs (serious) included any event such as death, life-threatening experience, in-subject hospitalisation, significant disability/ congential anomaly experienced from the trial product.


Secondary Outcome Measures :
  1. Antibody and Inhibitor Development [ Time Frame: From week 0 to week 52 ]
    All subjects who received rFXIII were monitored for anti-rFXIII antibodies and inhibitor development. Samples passed through 2 tiers of ELISA testing: an initial screen with a specific cut-off point (including ~5% false positives) and a second confirmatory assay for samples yielding a result above the screening cut-off point. If samples were confirmed as antibody positive in the confirmation assay, an inhibitor assay was also carried out to detect functional inhibitors. Percentage of subjects with antibody and inhibitor development were reported.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For subjects who participated in F13CD-1725:
  • Previous participation (means up to and inclusive Visit 16, (End of Trial)) in F13CD-1725
  • For all other subjects:
  • Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit or documented results from previously performed genotyping)
  • Body weight at least 20 kg

Exclusion Criteria:

  • Known neutralizing antibodies (inhibitors) towards FXIII
  • Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
  • Platelet count (thrombocytes) of less than 50 × 109/L. For subjects who participated in F13CD-1725 platelet count from visit 15 in F13CD-1725 must be used for evaluation.
  • Females of childbearing potential who are pregnant, breastfeeding or are not using adequate contraceptive methods

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978380


Locations
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United States, California
Novo Nordisk Investigational Site
Orange, California, United States, 92868
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322
United States, Idaho
Novo Nordisk Investigational Site
Boise, Idaho, United States, 83712
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55404
United States, Ohio
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43205
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
United States, Virginia
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98104
Austria
Novo Nordisk Investigational Site
Klagenfurt, Austria, A-9020
Canada, Ontario
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M5G 1X8
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00290
France
Novo Nordisk Investigational Site
Le Kremlin Bicetre, France, 94270
Novo Nordisk Investigational Site
Paris, France, 75015
Novo Nordisk Investigational Site
Rouen, France, 76031
Novo Nordisk Investigational Site
Valence Cedex 9, France, 26953
Germany
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Braunschweig, Germany, 38118
Novo Nordisk Investigational Site
Duisburg, Germany, 47051
Israel
Novo Nordisk Investigational Site
Petach Tikva, Israel, 49100
Italy
Novo Nordisk Investigational Site
Vicenza, Italy, 36100
Japan
Novo Nordisk Investigational Site
Hiroshima-shi, Hiroshima, Japan, 734 8551
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Málaga, Spain, 29011
Novo Nordisk Investigational Site
Tortosa, Spain, 43500
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
United Kingdom
Novo Nordisk Investigational Site
Aberdeen, United Kingdom, AB25 2ZN
Novo Nordisk Investigational Site
London, United Kingdom, WC1N 3JH
Novo Nordisk Investigational Site
Manchester, United Kingdom, M13 9WL
Novo Nordisk Investigational Site
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00978380    
Other Study ID Numbers: F13CD-3720
2008-007883-41 ( EudraCT Number )
U1111-1111-9289 ( Other Identifier: WHO )
JapicCTI-121958 ( Registry Identifier: JAPIC )
First Posted: September 16, 2009    Key Record Dates
Results First Posted: December 13, 2016
Last Update Posted: January 24, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Factor XIII Deficiency
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn