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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00056589
First Posted: March 20, 2003
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
March 18, 2003
March 20, 2003
January 11, 2017
March 2003
October 2003   (Final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: Days 0-28 ]
Not Provided
Complete list of historical versions of study NCT00056589 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency
A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Congenital FXIII Deficiency
Drug: catridecacog
Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).
Experimental: rFXIII
Intervention: Drug: catridecacog
Lovejoy AE, Reynolds TC, Visich JE, Butine MD, Young G, Belvedere MA, Blain RC, Pederson SM, Ishak LM, Nugent DJ. Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency. Blood. 2006 Jul 1;108(1):57-62. Epub 2006 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
October 2003
October 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00056589
F13-1663
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP