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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01561352

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Other Haemostasis Disorder Haemorrhagic Cystitis	Drug: activated recombinant human factor VII	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Nov 1, 2003

Actual Study Completion Date :

Nov 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Factor VII	Drug: activated recombinant human factor VII If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v.

Arm

Intervention/Treatment

Experimental: Factor VII

Drug: activated recombinant human factor VII

If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v.

Outcome Measures

Primary Outcome Measures

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 urine haemoglobin content []
Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit []

Secondary Outcome Measures

Symptoms of venous or arterial thrombosis []

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27599-7035
2	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27599-7400
3	Novo Nordisk Investigational Site	Houston	Texas	United States	77030-4009

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01561352

Other Study ID Numbers:

F7HAEM-2080

First Posted:

Mar 23, 2012

Last Update Posted:

Jan 12, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Cystitis

Study Results

No Results Posted as of Jan 12, 2017