Overview
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
Status:
Completed
Completed
Trial end date:
2003-11-01
2003-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the efficacy of activated recombinant human factor VII in the treatment of refractory haemorrhagic cystitis (HC) following chemotherapy.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novo Nordisk A/S
Criteria
Inclusion Criteria:- Severe haemorrhagic cystitis (HC)
Exclusion Criteria:
- Patients with overt DIC (disseminated intravascular coagulation)
- Patients with known active atherosclerotic disease, such as active coronary artery
disease or recent stroke in the past 3 months
- Central venous access device related thrombus in the last 3 months
- Patients with allergy to activated recombinant human factor VII or any component of
its preparation