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

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. Identifier: NCT00056589
Recruitment Status : Completed
First Posted : March 20, 2003
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Congenital FXIII Deficiency Drug: catridecacog Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
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
Study Start Date : March 2003
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Arm Intervention/treatment
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).

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

Secondary Outcome Measures :
  1. Incidence of clinically significant changes from baseline in physical examination or laboratory measurements [ Time Frame: Days 0-28 ]
  2. Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) [ Time Frame: Days 0-28 ]
  3. Incidence of yeast antibodies [ Time Frame: Days 0-28 ]
  4. FXIII activity measured by the Berichrom® assay [ Time Frame: Days 0-28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00056589

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United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00056589    
Other Study ID Numbers: F13-1663
First Posted: March 20, 2003    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders