Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

Posaconazole Oral Suspension and Itraconazole Oral Solution in Preventing Invasive Fungal Disease (IFD) in Patients With Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03631602

Enrollment

120

Registered

2018-08-15

Start date

2017-10-01

Completion date

2020-04-01

Last updated

2018-08-15

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

Conditions

IFD Post-HSCT

Brief summary

Invasive Fungal Disease (IFD) after haematopoietic stem cell transplantation (HSCT) remain a clinical challenge.The studay aims to compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.

Interventions

DRUGantifungal prophylaxis

posaconazole oral suspension vs itraconazole oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signed written informed consent Aged ≥13 years Patients undergoing hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70%

Exclusion criteria

* Pregnant or lactating females Any co-morbidity precluding the administration ofposaconazole or itraconazole

Design outcomes

Primary

Measure	Time frame
Incidence of breakthrough IFD	1 year

Secondary

Measure	Time frame
Overall survival	1 year
treatment-related mortality	1 year

Countries

China

Contacts

Primary ContactTing Yang, Prof.M.D.Ph.D

yang.hopeting@gmail.com86-13950210357

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026