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Completed

NCT Number: NCT01847989

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

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.

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Key information

Conditions

Congenital Bleeding Disorder Congenital FXIII Deficiency Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berkshire, SL1 2 AD, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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

Treatment and study plan

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).

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).

Primary outcomes

  1. Incidence of adverse events

    Time frame: Days 0-28

Secondary outcomes

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

    Time frame: Days 0-28

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

    Time frame: Days 0-28

  3. Incidence of yeast antibodies

    Time frame: Days 0-28

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
May 7, 2013
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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