Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
Phase 2
Completed
- Conditions
- Other Haemostasis DisorderHaemorrhagic 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Severe haemorrhagic cystitis (HC)
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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
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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