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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02239146

Enrollment

Registered

2014-09-12

Start date

2005-10-31

Completion date

2008-01-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

Brief summary

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).

Interventions

DRUGcatridecacog

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).

DRUGplacebo

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events	From dosing up to 5-7 weeks ± 3 days after trial product administration

Secondary

Measure	Time frame
Incidence of anti-yeast antibodies	From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence and magnitude of laboratory abnormalities following administration of rFXIII	From dosing up to 5-7 weeks ± 3 days after trial product administration
Incidence of antibodies to FXIII-A subunit	From dosing up to 5-7 weeks ± 3 days after trial product administration

Countries

Canada, Denmark, Germany, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026