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

Haemorrhagic Cystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561352
• Other study ID #: F7HAEM-2080
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2012
• Last updated: January 11, 2017
• Start date: September 2001
• Est. completion date: November 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Haemorrhagic Cystitis
• Other Haemostasis Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Chapel Hill	North Carolina
United States	Novo Nordisk Investigational Site	Chapel Hill	North Carolina
United States	Novo Nordisk Investigational Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color			No
Primary	Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content			No
Primary	Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit			No
Secondary	Symptoms of venous or arterial thrombosis			No

External Links

•   Clinical Trials at Novo Nordisk