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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01561352
First received: March 21, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes

March 21, 2012
May 22, 2012
September 2001
November 2003   (final data collection date for primary outcome measure)
  • Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color [ Designated as safety issue: No ]
  • Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content [ Designated as safety issue: No ]
  • Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01561352 on ClinicalTrials.gov Archive Site
Symptoms of venous or arterial thrombosis [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Haemostasis
  • Haemorrhagic Cystitis
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.
Experimental: Factor VII
Intervention: Drug: activated recombinant human factor VII
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
November 2003
November 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01561352
F7HAEM-2080
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Zhihui Lang Novo Nordisk
Novo Nordisk
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP