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ENROLLING BY INVITATION
NCT06698211

Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2023-08-01

Completion Date

2025-01-01

Last Updated

2024-11-20

Healthy Volunteers

No

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.

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, China