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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Other Haemostasis Disorder Haemorrhagic Cystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Factor VII

Group Type EXPERIMENTAL

activated recombinant human factor VII

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No