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

Phase 2

Completed

• Conditions: Other Haemostasis Disorder; Haemorrhagic Cystitis
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT01561352
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2003-11
• Study Completion: 2003-11
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Factor VII	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit
Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content

Secondary Outcome Measures

Name	Time	Method
Symptoms of venous or arterial thrombosis

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Houston, Texas, United States