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OpenTrials
Completed

NCT Number: NCT02239146

Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

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Key information

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is undergoing his/her first myocardial revascularization

Exclusion criteria

  • Previous participation (randomisation and dosing) in this trial
  • Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
  • Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
  • Subject has a current atrial fibrillation or history of atrial fibrillation

Treatment and study plan

catridecacog

Drug

Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Placebo

Drug

Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

Secondary outcomes

  1. Incidence and magnitude of laboratory abnormalities following administration of rFXIII

    Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

  2. Incidence of antibodies to FXIII-A subunit

    Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

  3. Incidence of anti-yeast antibodies

    Time frame: From dosing up to 5-7 weeks ± 3 days after trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2014
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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