Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

NCT01847989 | Completed Phase 1

• 1 other identifier: F13-1661
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Days 0-28

Secondary Outcomes (3)

• 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

Study Arms (2)

rFXIII

EXPERIMENTAL

Drug: catridecacog

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

catridecacog DRUG

Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

rFXIII

placebo DRUG

Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal platelet count and clotting parameters
• Adequate renal and hepatic function
• If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit
• 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:

• 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
• Any surgical procedure in the 30 days prior to enrollment
• Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus
• Receipt of treatment with any experimental agent within 30 days of study enrollment

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berkshire, SL1 2 AD, United Kingdom

Location

Related Publications (1)

• Visich JE, Zuckerman LA, Butine MD, Gunewardena KA, Wild R, Morton KM, Reynolds TC. Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers: a randomized, placebo-controlled, double-blind, multi-dose study. Thromb Haemost. 2005 Oct;94(4):802-7. doi: 10.1160/TH05-04-0292.

  PMID: 16270634 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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: January 1, 2003
• Primary Completion: May 1, 2003
• Study Completion: May 1, 2003
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

GB (1)