CompletedPhase 2

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

United States7 participantsStarted 2001-09

Plain-language 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.

Who can participate

Age range2 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color

Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content

Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit

Trial details

NCT IDNCT01561352

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-11

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