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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: March 18, 2003
Last updated: January 10, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Congenital Bleeding Disorder Congenital FXIII Deficiency Drug: catridecacog Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Days 0-28 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: March 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFXIII 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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00056589

United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00056589     History of Changes
Other Study ID Numbers: F13-1663
Study First Received: March 18, 2003
Last Updated: January 10, 2017

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders processed this record on September 21, 2017