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

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Acquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary Bypass
Interventions
DRUG

catridecacog

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).

DRUG

placebo

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).

Trial Locations (24)

2100

Novo Nordisk Investigational Site, København Ø

10032

Novo Nordisk Investigational Site, New York

10461

Novo Nordisk Investigational Site, The Bronx

10467

Novo Nordisk Investigational Site, The Bronx

18103

Novo Nordisk Investigational Site, Allentown

20246

Novo Nordisk Investigational Site, Hamburg

23298

Novo Nordisk Investigational Site, Richmond

44195

Novo Nordisk Investigational Site, Cleveland

46290

Novo Nordisk Investigational Site, Indianapolis

55131

Novo Nordisk Investigational Site, Mainz

77030

Novo Nordisk Investigational Site, Houston

77933

Novo Nordisk Investigational Site, Lahr

80262

Novo Nordisk Investigational Site, Denver

85714

Novo Nordisk Investigational Site, Tucson

94143

Novo Nordisk Investigational Site, San Francisco

97207

Novo Nordisk Investigational Site, Portland

08103

Novo Nordisk Investigational Site, Camden

97239-3098

Novo Nordisk Investigational Site, Portland

19107-5092

Novo Nordisk Investigational Site, Philadelphia

M5G-2C4

Novo Nordisk Investigational Site, Toronto

CB3 8RE

Novo Nordisk Investigational Site, Cambridge

W1G 8PH

Novo Nordisk Investigational Site, London

TS4 3BW

Novo Nordisk Investigational Site, Middlesbrough

SO16 6YD

Novo Nordisk Investigational Site, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY