- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561352
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
January 11, 2017 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7035
- Novo Nordisk Investigational Site
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Chapel Hill, North Carolina, United States, 27599-7400
- Novo Nordisk Investigational Site
-
-
Texas
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Houston, Texas, United States, 77030-4009
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Symptoms of venous or arterial thrombosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
November 1, 2003
Study Completion (Actual)
November 1, 2003
Study Registration Dates
First Submitted
March 21, 2012
First Submitted That Met QC Criteria
March 22, 2012
First Posted (Estimate)
March 23, 2012
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F7HAEM-2080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on activated recombinant human factor VII
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Novo Nordisk A/SCompletedHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseFrance
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Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Intracerebral HaemorrhageSpain, Sweden, Singapore, Norway, Italy, Switzerland, Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Netherlands, United Kingdom
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Novo Nordisk A/SCompletedHealthy | Congenital Bleeding DisorderUnited States
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Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A | Haemophilia BFrance, Israel, Germany
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Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Cardiac Surgery Requiring Cardiopulmonary BypassUnited States, Spain, Germany, Sweden, United Kingdom, Argentina, Italy, Brazil, Denmark, France, India, Malaysia, Singapore, South Africa
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With InhibitorsFrance, United Kingdom, Spain, Israel, Poland, Turkey, Hungary
-
Novo Nordisk A/SCompletedObservational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII DeficiencyCongenital Bleeding Disorder | Congenital FVII DeficiencyJapan
-
Novo Nordisk A/SCompletedCirrhosis | Acquired Bleeding DisorderGermany, United Kingdom, Spain, Taiwan, France, Italy, Austria, Czech Republic, Poland, Denmark, Finland, Hong Kong
-
Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderIndia, Spain, Canada, Finland, Germany, Israel, Italy, Netherlands, Singapore, Switzerland, Taiwan