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

Congenital Bleeding Disorder Clinical Trial

Official title:

A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056589
• Other study ID #: F13-1663
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2003
• Last updated: January 10, 2017
• Start date: March 2003
• Est. completion date: October 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Congenital FXIII Deficiency
• Hemostatic Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Days 0-28	No
Secondary	Incidence of clinically significant changes from baseline in physical examination or laboratory measurements		Days 0-28	No
Secondary	Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)		Days 0-28	No
Secondary	Incidence of yeast antibodies		Days 0-28	No
Secondary	FXIII activity measured by the Berichrom® assay		Days 0-28	No

External Links

•   Clinical Trials at Novo Nordisk