NCT01561391 - Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 30, 1998

Primary Completion Date

May 31, 2004

Study Completion Date

May 31, 2004

Conditions

Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors

Interventions

DRUG

activated recombinant human factor VII

Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.

DRUG

activated recombinant human factor VII

Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.

OTHER

factor IX

Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.

DRUG

factor VIII

Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.

Trial Locations (14)

17033

Novo Nordisk Investigational Site, Hershey

19104

Novo Nordisk Investigational Site, Philadelphia

19107

Novo Nordisk Investigational Site, Philadelphia

55905

Novo Nordisk Investigational Site, Rochester

60611

Novo Nordisk Investigational Site, Chicago

60612

Novo Nordisk Investigational Site, Chicago

70112

Novo Nordisk Investigational Site, New Orleans

77030

Novo Nordisk Investigational Site, Houston

87106

Novo Nordisk Investigational Site, Albuquerque

90027

Novo Nordisk Investigational Site, Los Angeles

02115

Novo Nordisk Investigational Site, Boston

08903

Novo Nordisk Investigational Site, New Brunswick

10029-6574

Novo Nordisk Investigational Site, New York

27599-7220

Novo Nordisk Investigational Site, Chapel Hill