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

NCT01561352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

  • Other Haemostasis Disorder
  • Haemorrhagic Cystitis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2003-11-30
Completion
2003-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01561352 on ClinicalTrials.gov