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Enrolling by invitation NCT06698211

Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

— Observational Invasive Fungal Disease Graft Versus Host Disease Hematopoietic Stem Cell Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Posaconazole tablet.
Who it may be relevant to
Registry conditions: Invasive Fungal Disease, Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Posaconazole Tablet As Primary Prophylaxis of Hematopoietic Stem Cell Transplant Patients with Gastrointestinal GVHD

Overview

This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined.

Detailed description

This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. The primary endpoint was the incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection

Interventions

  • Drug Posaconazole tablet
    Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to

Primary outcome measures

  • primary endpoint [Time frame: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis]
Secondary outcome measures (3)
  • 2 [Time frame: Day 5 after posaconazole administration, and Days 1, 3, and 7 after the onset of gastrointestinal GVHD]
  • 3 [Time frame: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.]
  • 4 [Time frame: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.]

Eligibility criteria

Inclusion criteria

  • Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation.
  • Patients who receive Posaconazole tablet as primary prophylaxis of invasive fungal disease.
  • Patients developing or developed acute gastrointestinal GVHD which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.

Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.

  • Patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent

Exclusion criteria

  • refuse to enroll
  • patients have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used.
  • pregnant or lactating females
  • take drugs known to interfere with azole antifungal agents, including terfenadine, cisapride and ebastine, within 24h before Posaconazole application; astemizole at enrollment or within 10 days before Posaconazole application; or cimetidine, rifampin, carbamazepine, phenytoin, rifamycin, barbiturates, isoniazid, catharanthine and anthracyclines within 24 h before Posaconazole application
  • have an ECG with a prolonged QTc interval (QTc greater than 500 ms);
  • have severe renal insufficiency, alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin levels more than two-times the upper limit of normal;
  • patients are expected to survive no more than 72 h;
  • Those with evidence of active fungal infection within 3 weeks prior to enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & P — Tianjin

Identifiers

NCT: NCT06698211 · QTJC2024039

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗