Completed PHASE1 INTERVENTIONAL 2-arm NCT02239146

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

Sponsor: Novo Nordisk A/S

Conditions Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions catridecacog placebo

Updated 7 times since 2017 Last updated: Jan 10, 2017 Started: Oct 31, 2005 Primary completion: Jan 31, 2008 Completion: Jan 31, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass and is currently completed. Novo Nordisk A/S leads this study, which shows 7 recorded versions since 2005 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Oct 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novo Nordisk A/S

Data source: Novo Nordisk A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Allentown, United States , Cambridge, United Kingdom , Camden, United States , Cleveland, United States , Denver, United States , Hamburg, Germany , Houston, United States , Indianapolis, United States , København Ø, Denmark , Lahr, Germany and 12 more locations