Back to resultsEfficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
Primary Purpose
Other Haemostasis Disorder, Haemorrhagic Cystitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
activated recombinant human factor VII
Sponsored by
About this trial
This is an interventional treatment trial for Other Haemostasis Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Factor VII
Arm Description
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01561352
Brief Title
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
November 2003 (Actual)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Haemostasis Disorder, Haemorrhagic Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Factor VII
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
Title
Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content
Title
Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit
Secondary Outcome Measure Information:
Title
Symptoms of venous or arterial thrombosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7035
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7400
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17133240
Citation
Ashrani AA, Gabriel DA, Gajewski JL, Jacobs DR Jr, Weisdorf DJ, Key NS. Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy. Bone Marrow Transplant. 2006 Dec;38(12):825-8. doi: 10.1038/sj.bmt.1705535. No abstract available.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
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