NCT02239146|CompletedPhase 1DMC

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

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

F13CARD-16602005-000729-40

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredSep 2014

StartedOct 2005

CompletionJan 2008

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Oct 2005

Typical duration for phase_1

Geographic Reach

5 countries

24 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

October 1, 2005

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

6.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed

Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

September 10, 2014

Last Update Submit

January 10, 2017

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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
Incidence of anti-yeast antibodies
From dosing up to 5-7 weeks ± 3 days after trial product administration

Study Arms (2)

rFXIII

EXPERIMENTAL

Drug: catridecacog

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

catridecacogDRUG

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).

rFXIII

placeboDRUG

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).

Placebo

Eligibility Criteria

Age35 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject is undergoing his/her first myocardial revascularization

You may not qualify if:

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

Contact the study team to confirm eligibility.