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Myfortic - Treatment for Extensive cGvHD

NCT00298324 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-04-03

No results posted yet for this study

Summary

The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

Conditions

  • Graft vs Host Disease

Interventions

DRUG

Myfortic

1440mg twice daily

DRUG

Prednisone and Cyclosporine

Prednisone and Cyclosporine given according to protocol. The drugs are tapered according to patient response

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • European Society for Blood and Marrow Transplantation

    lead NETWORK

Principal Investigators

  • Gérard Socié · Hôptial St Louis, Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-11-30
Completion
2010-11-30

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT00298324 on ClinicalTrials.gov