Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD
NCT06698211 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2024-11-20
Summary
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.
Conditions
- Invasive Fungal Disease
- Graft Versus Host Disease
- Hematopoietic Stem Cell Transplantation
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 monitor the impact of GI GVHD on the Posaconazole plasma concentration.
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Principal Investigators
-
Aiming Pang, doctor · Hematopoietic stem cell transplantation Center
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-01
- Primary Completion
- 2024-12-01
- Completion
- 2025-01-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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