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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01561352
First received: March 21, 2012
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Other Haemostasis Disorder
Haemorrhagic Cystitis
Drug: activated recombinant human factor VII
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Symptoms of venous or arterial thrombosis [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: September 2001
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561352

Locations
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7400
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7035
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Zhihui Lang Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01561352     History of Changes
Other Study ID Numbers: F7HAEM-2080
Study First Received: March 21, 2012
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystitis
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014