Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

September 30, 2001

Primary Completion Date

November 30, 2003

Study Completion Date

November 30, 2003

Conditions
Other Haemostasis DisorderHaemorrhagic Cystitis
Interventions
DRUG

activated recombinant human factor VII

If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v.

Trial Locations (3)

27599-7035

Novo Nordisk Investigational Site, Chapel Hill

27599-7400

Novo Nordisk Investigational Site, Chapel Hill

77030-4009

Novo Nordisk Investigational Site, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY