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

NCT00056589 | Completed Phase 1

• 1 other identifier: F13-1663
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Bleeding Disorder; Congenital FXIII Deficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Days 0-28

Secondary Outcomes (4)

• Incidence of clinically significant changes from baseline in physical examination or laboratory measurements

  Days 0-28

• Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)

  Days 0-28

• Incidence of yeast antibodies

  Days 0-28

• FXIII activity measured by the Berichrom® assay

  Days 0-28

Study Arms (1)

rFXIII

EXPERIMENTAL

Drug: catridecacog

Interventions

catridecacog DRUG

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).

rFXIII

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Los Angeles, California, 90027, United States

Location

Related 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 1;108(1):57-62. doi: 10.1182/blood-2005-02-0788. Epub 2006 Mar 23.

  PMID: 16556896 RESULT

Related Links

• Clinical Trials at Novo Nordisk

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2003
• First Posted: March 20, 2003
• Study Start: March 1, 2003
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (1)