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

Haemorrhagic Cystitis Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Haemorrhagic Cystitis
• Other Haemostasis Disorder

• NCT number: NCT01561352
• Study type: Interventional
• Source: Novo Nordisk A/S
• Status: Completed
• Phase: Phase 2
• Start date: September 2001
• Completion date: November 2003