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A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines

NCT00548704 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-10-21

No results posted yet for this study

Summary

The purpose of this study is

* To prevent progression of a lesion caused by anthracycline extravasation into necrosis, which would require surgical intervention
* To prevent development of deep tissue necrosis and destruction leading to impaired limb function and neurological deficit
* To prevent postponement of the scheduled cancer treatment due to the treatment of the extravasation

Conditions

  • Extravasation

Interventions

DRUG

Dexrazoxane

Sponsors & Collaborators

  • Valerio Therapeutics

    lead INDUSTRY

Principal Investigators

  • Henning T Mouridsen, MD, Dr. med. · Rigshospitalet, The Finsen Centre 5074, Blegdamsvej 9, DK-2100 Copenhagen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Poland

Study Locations

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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 NCT00548704 on ClinicalTrials.gov