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

Completed · Phase 2

Conditions studied: Other Haemostasis Disorder, Haemorrhagic Cystitis

In brief

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.

Key facts

Study ID

NCT01561352

Run by

Novo Nordisk A/S

People needed

7

Starts

2001-09-01

Expected to finish

2003-11-01

Last updated by the study team

2017-01-12

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe haemorrhagic cystitis (HC)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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