Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

November 30, 2002

Study Completion Date

November 30, 2002

Conditions
Acquired Bleeding DisorderDengue Haemorrhagic Fever
Interventions
DRUG

activated recombinant human factor VII

100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.

DRUG

placebo

100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.

Trial Locations (9)

10400

Novo Nordisk Investigational Site, Bangkok

34000

Novo Nordisk Investigational Site, Ubonratchathani

40000

Novo Nordisk Investigational Site, Khon Kaen

50200

Novo Nordisk Investigational Site, Chiang Mai

65000

Novo Nordisk Investigational Site, Pisanulok

Unknown

Novo Nordisk Investigational Site, Kuala Lumpur

Novo Nordisk Investigational Site, City of Muntinlupa

Novo Nordisk Investigational Site, Manila

Novo Nordisk Investigational Site, Quezon City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY