Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Phase 1

Completed

• Conditions: Congenital FXIII Deficiency; Congenital Bleeding Disorder; Healthy
• Interventions: Drug: catridecacog; Drug: placebo

• Registration Number: NCT01848002
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Normal platelet count and clotting parameters
• Adequate renal and hepatic function
• Negative serum pregnancy test within 21 days prior to enrollment and negative urine pregnancy test on admission to the clinical research unit (if subject female and 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 (if subject a sexually active male or female of childbearing potential)
• Negative drug and negative alcohol screens

Exclusion Criteria

• Known antibodies or hypersensitivity to FXIII
• Known bleeding or hematologic disorder
• Known allergy to yeast
• Receipt of blood products within 30 days of screening
• Donation of blood within 30 days prior to enrollment
• Surgical procedure of any type within 30 days prior to enrollment
• History of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
• Treatment with any experimental agent within 30 days of study enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rFXIII	catridecacog	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	Days 0-33

Secondary Outcome Measures

Name	Time	Method
Incidence of clinically significant changes from baseline in physical examination or laboratory measurements	From days -1 through day 33
Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)	From days -1 through day 33
Incidence of yeast antibodies	From days -1 through day 33