Phase 3 N=63 Prevention

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

Congenital Bleeding Disorder · Congenital FXIII Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00978380 ↗

Enrolled (actual)

Serious AEs

14.1%

Results posted

Dec 2016

Primary outcome: Primary: Adverse Events (AEs)(Serious and Non-serious) — 920; 19; 901 Events

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: catridecacog (Drug)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Novo Nordisk A/S
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events (AEs)(Serious and Non-serious)	920; 19; 901	—
SECONDARY Antibody and Inhibitor Development	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00978380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.