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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Haemorrhagic Cystitis; Other Haemostasis Disorder

Treatments: Drug: activated recombinant human factor VII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561352

F7HAEM-2080

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Factor VII

Experimental group

Treatment:

Drug: activated recombinant human factor VII