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

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 21, 2009

Primary Completion Date

October 20, 2015

Study Completion Date

October 20, 2015

Conditions
Congenital Bleeding DisorderCongenital FXIII Deficiency
Interventions
DRUG

catridecacog

Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)

Trial Locations (34)

8091

Novo Nordisk Investigational Site, Zurich

17033

Novo Nordisk Investigational Site, Hershey

20007

Novo Nordisk Investigational Site, Washington D.C.

23219

Novo Nordisk Investigational Site, Richmond

26953

Novo Nordisk Investigational Site, Valence

29011

Novo Nordisk Investigational Site, Málaga

30322

Novo Nordisk Investigational Site, Atlanta

33607

Novo Nordisk Investigational Site, Tampa

36100

Novo Nordisk Investigational Site, Vicenza

38118

Novo Nordisk Investigational Site, Braunschweig

43205

Novo Nordisk Investigational Site, Columbus

43500

Novo Nordisk Investigational Site, Tortosa

47051

Novo Nordisk Investigational Site, Duisburg

48201

Novo Nordisk Investigational Site, Detroit

49100

Novo Nordisk Investigational Site, Petah Tikva

53127

Novo Nordisk Investigational Site, Bonn

55404

Novo Nordisk Investigational Site, Minneapolis

73104

Novo Nordisk Investigational Site, Oklahoma City

75015

Novo Nordisk Investigational Site, Paris

76031

Novo Nordisk Investigational Site, Rouen

83712

Novo Nordisk Investigational Site, Boise

92868

Novo Nordisk Investigational Site, Orange

94270

Novo Nordisk Investigational Site, Le Kremlin-Bicêtre

98104

Novo Nordisk Investigational Site, Seattle

A-9020

Novo Nordisk Investigational Site, Klagenfurt

M5G 1X8

Novo Nordisk Investigational Site, Toronto

00290

Novo Nordisk Investigational Site, Helsinki

734 8551

Novo Nordisk Investigational Site, Hiroshima-shi, Hiroshima

160 0023

Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo

08035

Novo Nordisk Investigational Site, Barcelona

AB25 2ZN

Novo Nordisk Investigational Site, Aberdeen

WC1N 3JH

Novo Nordisk Investigational Site, London

M13 9WL

Novo Nordisk Investigational Site, Manchester

NE1 4LP

Novo Nordisk Investigational Site, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT00978380 - Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725 | Biotech Hunter | Biotech Hunter