Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency
• Interventions: Drug: catridecacog

• Registration Number: NCT00056589
• Lead Sponsor: Novo Nordisk A/S

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 Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-03-18
• Study First Submitted QC: 2003-03-19
• Study First Posted: 2003-03-20
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Documental congenital FXIII deficiency
• Normal platelet count and clotting parameters
• Adequate renal and hepatic function
• If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
• If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
• Negative drug and alcohol screens

Exclusion Criteria

• Received blood products or FXIII concentrates within 4 weeks of study enrollment
• Known antibodies to FXIII
• Hereditary or acquired coagulation disorder other than FXIII deficiency
• Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
• Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
• Received treatment with any experimental agent within 30 days of study enrollment
• Any surgical procedure in the 30 days prior to enrollment
• Donated blood within 30 days prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rFXIII	catridecacog	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Days 0-28

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements	Days 0-28
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)	Days 0-28
Incidence of yeast antibodies	Days 0-28
FXIII activity measured by the Berichrom® assay	Days 0-28

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Los Angeles, California, United States