Haemorrhagic Cystitis, Other Haemostasis Disorder
Conditions
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.
Interventions
DRUGactivated 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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Symptoms of venous or arterial thrombosis | — |
Countries
United States
Outcome results
None listed