Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848002
• Other study ID #: F13-1662
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2013
• Last updated: November 25, 2013
• Start date: May 2003
• Est. completion date: August 2003

Study information

• Verified date: November 2013
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• catridecacog
For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).
• placebo
For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Days 0-33	No
Secondary	Incidence of clinically significant changes from baseline in physical examination or laboratory measurements		From days -1 through day 33	No
Secondary	Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)		From days -1 through day 33	No
Secondary	Incidence of yeast antibodies		From days -1 through day 33	No

External Links

•   Clinical Trials at Novo Nordisk