Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
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
1 other identifier
interventional
7
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2001
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedJanuary 12, 2017
January 1, 2017
2.2 years
March 21, 2012
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Symptoms of venous or arterial thrombosis
Study Arms (1)
Factor VII
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Severe haemorrhagic cystitis (HC)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (3)
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7035, United States
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7400, United States
Novo Nordisk Investigational Site
Houston, Texas, 77030-4009, United States
Related Publications (1)
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.
PMID: 17133240RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
September 1, 2001
Primary Completion
November 1, 2003
Study Completion
November 1, 2003
Last Updated
January 12, 2017
Record last verified: 2017-01