Status:
COMPLETED
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Congenital FXIII Deficiency
Eligibility:
All Genders
6+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2015
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00978380
Start Date
September 21 2009
End Date
October 20 2015
Last Update
January 24 2018
Active Locations (34)
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1
Novo Nordisk Investigational Site
Orange, California, United States, 92868
2
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, United States, 20007
3
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
4
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322