Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD (NCT06698211) | Clinical Trial Compass
By InvitationNot Applicable
Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD
China40 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
✓. 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;
What they're measuring
1
primary endpoint
Timeframe: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis
Trial details
NCT IDNCT06698211
SponsorInstitute of Hematology & Blood Diseases Hospital, China