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

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Congenital FXIII Deficiency

In brief

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.

Key facts

Study ID

NCT00978380

Run by

Novo Nordisk A/S

People needed

63

Starts

2009-09-21

Expected to finish

2015-10-20

Last updated by the study team

2018-01-24

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Boise, Idaho, 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 — Oklahoma City, Oklahoma, United States
• Novo Nordisk Investigational Site — Hershey, Pennsylvania, United States
• Novo Nordisk Investigational Site — Richmond, Virginia, United States
• Novo Nordisk Investigational Site — Seattle, Washington, United States
• Novo Nordisk Investigational Site — Klagenfurt, Austria
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Helsinki, Finland
• Novo Nordisk Investigational Site — Le Kremlin-Bicêtre, France
• Novo Nordisk Investigational Site — Paris, France
• Novo Nordisk Investigational Site — Rouen, France
• Novo Nordisk Investigational Site — Valence, France
• Novo Nordisk Investigational Site — Bonn, Germany
• Novo Nordisk Investigational Site — Braunschweig, Germany
• Novo Nordisk Investigational Site — Duisburg, Germany
• Novo Nordisk Investigational Site — Petah Tikva, Israel
• Novo Nordisk Investigational Site — Vicenza, Italy
• Novo Nordisk Investigational Site — Hiroshima-shi, Hiroshima, Japan

Full record on ClinicalTrials.gov

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