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

Status:	Completed
Conditions:	Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	6 - Any
Updated:	1/26/2018
Start Date:	September 21, 2009
End Date:	October 20, 2015

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

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.

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

We found this trial at

sites

Novo Nordisk Investigational Site

Tampa, Florida 33612

from

Tampa, FL