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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Congenital FXIII Deficiency

Congenital Bleeding Disorder

Treatments

Drug: catridecacog

Study type

Interventional

Funder types

Industry

Identifiers

NCT00978380

JapicCTI-121958 (Registry Identifier)

U1111-1111-9289 (Other Identifier)

2008-007883-41 (EudraCT Number)

F13CD-3720

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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