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Completed

NCT Number: NCT01561352

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

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.

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Key information

Conditions

Other Haemostasis Disorder Cystitis Cystitis, Hemorrhagic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Haemorrhagic Cystitis Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

2 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Chapel Hill, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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 outcomes

  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 outcomes

  1. Symptoms of venous or arterial thrombosis

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Mar 23, 2012
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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