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Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01561352
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Other Haemostasis Disorder Haemorrhagic Cystitis Drug: activated recombinant human factor VII Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2001
Actual Primary Completion Date : November 2003
Actual Study Completion Date : November 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Factor VII Drug: activated 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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color
  2. Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content
  3. Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit

Secondary Outcome Measures :
  1. Symptoms of venous or arterial thrombosis

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561352


Locations
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United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7035
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7400
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561352    
Other Study ID Numbers: F7HAEM-2080
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Cystitis
Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases