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Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

NCT00563108 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-07-07

No results posted yet for this study

Summary

Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).

Conditions

  • Graft vs Host Disease
  • Hematopoietic Stem Cell Transplantation

Interventions

DRUG

Basiliximab

DRUG

Placebo

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • The Hong Kong Blood Cancer Foundation

    collaborator OTHER

  • Hospital Authority, Hong Kong

    lead OTHER_GOV

Principal Investigators

  • Lawrence SY Ma, Dr · Department of Medicine/ Haematology and Oncology, Queen Mary Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Completion
2008-12-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT00563108 on ClinicalTrials.gov