Clinical Trial: Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency
Brief Summary: This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Incidence of adverse events [ Time Frame: Days 0-28 ]
Original Primary Outcome:
Current Secondary Outcome:
- Incidence of clinically significant changes from baseline in physical examination or laboratory measurements [ Time Frame: Days 0-28 ]
- Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) [ Time Frame: Days 0-28 ]
- Incidence of yeast antibodies [ Time Frame: Days 0-28 ]
- FXIII activity measured by the Berichrom® assay [ Time Frame: Days 0-28 ]
Original Secondary Outcome:
Information By: Novo Nordisk A/S
Dates:
Date Received: March 18, 2003
Date Started: March 2003
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017
