catridecacog

DRUG13 trials

Sponsors

Novo Nordisk A/S

Conditions

Acquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary BypassCongenital Bleeding DisorderCongenital FXIII DeficiencyHealthyInflammationUlcerative Colitis

Phase 1

Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

CompletedNCT00056589

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency

Start: 2003-03-31End: 2003-10-31Updated: 2017-01-11

Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

CompletedNCT01082406

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Start: 2010-03-31End: 2010-07-31Updated: 2016-09-21

Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers

CompletedNCT01153997

Novo Nordisk A/SAcquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass, Healthy

Start: 2010-06-30End: 2010-08-31Updated: 2014-06-18

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

CompletedNCT01847989

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Start: 2003-01-31End: 2003-05-31Updated: 2017-01-11

Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

CompletedNCT01848002

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Start: 2003-05-31End: 2003-08-31Updated: 2013-11-26

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

CompletedNCT02239146

Novo Nordisk A/SAcquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

Start: 2005-10-31End: 2008-01-31Updated: 2017-01-11

Phase 2

Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

CompletedNCT00914589

Novo Nordisk A/SAcquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

Start: 2009-07-31End: 2011-02-28Updated: 2017-03-07

A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

TerminatedNCT01706159

Novo Nordisk A/SInflammation, Ulcerative Colitis

Start: 2012-10-31End: 2013-07-31Updated: 2014-10-02

Phase 3

Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

CompletedNCT00713648

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency

Start: 2008-08-31End: 2010-04-30Updated: 2017-02-24

Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725

CompletedNCT00978380

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency

Start: 2009-09-21End: 2015-10-20Updated: 2018-01-24

Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency

CompletedNCT01230021

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency

Start: 2010-11-30End: 2012-01-31Updated: 2017-02-24

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

CompletedNCT01253811

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency

Start: 2011-01-31End: 2015-03-31Updated: 2016-06-24

Unknown Phase

Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

CompletedNCT01862367

Novo Nordisk A/SCongenital Bleeding Disorder, Congenital FXIII Deficiency

Start: 2013-05-17End: 2019-06-26Updated: 2019-07-09

Related Papers

Reciprocal stabilization of coagulation factor XIII-A and -B subunits is a determinant of plasma FXIII concentration

UNC Libraries2026-04-24

Reciprocal stabilization of coagulation factor XIII-A and -B subunits is a determinant of plasma FXIII concentration

Blood2023-10-2610 citations

Recombinant FXIII (rFXIII-A2) Prophylaxis Prevents Bleeding and Allows for Surgery in Patients with Congenital FXIII A-Subunit Deficiency

Thrombosis and Haemostasis2018-02-1524 citations

Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: a randomized, placebo-controlled, multicenter clinical trial.

2013-06-2962 citations

Recombinant factor XIII: a safe and novel treatment for congenital factor XIII deficiency.

2012-03-2681 citations