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NCT01160952

Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation

Status unknown Phase 2 Last updated 23 July 2010
What this trial tests

Phase 2 trial testing itraconazole in Hematological Diseases in 120 participants. Status unknown.

Timeline
1 May 2009
Primary endpoint
1 December 2010
1 March 2011

Quick facts

Lead sponsorGuangzhou General Hospital of Guangzhou Military Command
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment120
Start date1 May 2009
Primary completion1 December 2010
Estimated completion1 March 2011
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Who can join

Adults 14 to 60, any sex, with Hematological Diseases or Allogeneic Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

* The primary objective of this study is to evaluate the efficacy and safety profile of itraconazole as in primary prophylaxis * The second objective of this study is to find the difference between long-term versus short-term sequential therapy of Itraconazole (intravenous followed by oral itraconazole) as primary prophylaxis of invasive fungal infections (IFI) in patients undergoing allogeneic stem cell transplantation (allo-SCT) * also to explore the relationship between the incidence of IFI with plasma concentrations of itraconazole and hydroxy-itraconazole

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 18th Congress of the European Hematology Association, Stockholm, Sweden, June 13–16, 2013
    · 2013

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Other trials of itraconazole

Trials testing the same drug.

Other recruiting trials for Hematological Diseases

Currently open trials in the same condition.

Other Guangzhou General Hospital of Guangzhou Military Command trials

Trials by the same sponsor.

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Data sources for this page

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