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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00056589
First received: March 18, 2003
Last updated: May 2, 2013
Last verified: May 2013
History of Changes

March 18, 2003
May 2, 2013
March 2003
October 2003   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
  • Incidence of yeast antibodies [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
  • FXIII activity measured by the Berichrom® assay [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
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 recombinant factor XIII (rFXIII) in patients with congenital factor XIII deficiency.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Congenital FXIII Deficiency
Drug: recombinant factor XIII
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: recombinant factor XIII
Not Provided

*   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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00056589
F13-1663
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk
Novo Nordisk
May 2013

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