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OpenTrials
Completed

NCT Number: NCT00034645

Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

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Key information

Conditions

Mycoses Bacterial Infections and Mycoses Infections

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute GVHD being treated with high dose immunosuppressive therapy.
  • One of the following to the subject's prior immunosuppressive regimen:
  • at least 1mg per kg per day of methylprednisolone or equivalent,
  • Antithymocyte globulin (ATG) for the therapy of acute GVHD,
  • Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Treatment and study plan

Posaconazole oral suspension

Drug

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Important dates

Study start
1999
Primary completion
2003
Study completion
2003
First posted
May 2, 2002
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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