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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034645

Enrollment

600

Registered

2002-05-02

Start date

1999-01-31

Completion date

2003-02-28

Last updated

2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoses

Keywords

Allogenic Stem cell transplantation, Fungal infections

Brief summary

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).

Detailed description

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.

Interventions

DRUGPosaconazole oral suspension

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

13 Years to 65 Years

Healthy volunteers

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: 1. at least 1mg per kg per day of methylprednisolone or equivalent, 2. Antithymocyte globulin (ATG) for the therapy of acute GVHD, 3. Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026