Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
| Status: | Completed |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 2 - 65 |
| Updated: | 1/13/2017 |
| Start Date: | September 2001 |
| End Date: | November 2003 |
An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High Dose Chemotherapy
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.
assess the efficacy of activated recombinant human factor VII in the treatment of refractory
haemorrhagic cystitis (HC) following chemotherapy.
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
We found this trial at
2
sites
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