Catridecacog

Generic Name: Catridecacog

Brand Names: Novothirteen, Tretten, NovoThirteen

Drug Type: Biotech

Chemical Formula: -

CAS Number: 606138-08-3

Unique Ingredient Identifier: NU23Q531G1

Background: Coagulation Factor XIII A-Subunit (Recombinant), also known as catridecacog, is a recombinant form of the Factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits . For people with congenital deficiency or mutation of Factor XIII, a rare bleeding disorder, exogenous replacement of this key coagulation factor is essential for management and pre...

Indication: For routine prophylaxis of bleeding in patients with congenital factor XIII A-Subunit deficiency.

Associated Conditions: Bleeding

Associated Therapies: -

Clinical Trials

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

Phase 1

Completed

Conditions: Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions: Drug: placebo
Drug: catridecacog

First Posted Date: 2014-09-12

Last Posted Date: 2017-01-11

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 43

Registration Number: NCT02239146

Locations: 🇬🇧
Novo Nordisk Investigational Site, Southampton, United Kingdom

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

Completed

Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency

Interventions: Drug: catridecacog

First Posted Date: 2013-05-24

Last Posted Date: 2019-07-09

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 30

Registration Number: NCT01862367

Locations: 🇬🇧
Novo Nordisk Investigational Site, Aberdeen, United Kingdom

Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers

Phase 1

Completed

Conditions: Congenital FXIII Deficiency
Congenital Bleeding Disorder
Healthy

Interventions: Drug: catridecacog
Drug: placebo

First Posted Date: 2013-05-07

Last Posted Date: 2013-11-26

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 24

Registration Number: NCT01848002

Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Phase 1

Completed

Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency
Healthy

Interventions: Drug: placebo
Drug: catridecacog

First Posted Date: 2013-05-07

Last Posted Date: 2017-01-11

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 50

Registration Number: NCT01847989

Locations: 🇬🇧
Novo Nordisk Investigational Site, Berkshire, United Kingdom

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

Phase 2

Terminated

Conditions: Ulcerative Colitis
Inflammation

Interventions: Drug: placebo
Drug: catridecacog

First Posted Date: 2012-10-15

Last Posted Date: 2014-10-02

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 20

Registration Number: NCT01706159

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

Phase 3

Completed

Conditions: Congenital FXIII Deficiency
Congenital Bleeding Disorder

Interventions: Drug: catridecacog

First Posted Date: 2010-12-03

Last Posted Date: 2016-06-24

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 6

Registration Number: NCT01253811

Locations: 🇺🇸
Novo Nordisk Clinical Trial Call Center, Columbus, Ohio, United States

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

Phase 3

Completed

Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency

Interventions: Drug: catridecacog

First Posted Date: 2010-10-28

Last Posted Date: 2017-02-24

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 6

Registration Number: NCT01230021

Locations: 🇬🇧
Novo Nordisk Investigational Site, Reading, United Kingdom

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

Phase 1

Completed

Conditions: Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Healthy

Interventions: Drug: placebo
Drug: catridecacog

First Posted Date: 2010-06-30

Last Posted Date: 2014-06-18

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 24

Registration Number: NCT01153997

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

Phase 1

Completed

Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency
Healthy

Interventions: Drug: recombinant factor XIII
Drug: catridecacog

First Posted Date: 2010-03-08

Last Posted Date: 2016-09-21

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 51

Registration Number: NCT01082406

Locations: 🇬🇧
Novo Nordisk Investigational Site, Harrow, United Kingdom

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

Phase 3

Completed

Conditions: Congenital Bleeding Disorder
Congenital FXIII Deficiency

Interventions: Drug: catridecacog

First Posted Date: 2009-09-16

Last Posted Date: 2018-01-24

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 63

Registration Number: NCT00978380

Locations: 🇬🇧
Novo Nordisk Investigational Site, Newcastle upon Tyne, United Kingdom

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