Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

NCT06698211 | Enrolling By Invitation FDA Drug

• 1 other identifier: QTJC2024039
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hematopoietic stem cell transplantation; graft versus host disease; invasive fungal disease; primary prophylaxis

Outcome Measures

Primary Outcomes (1)

• primary endpoint

  1\. The incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection

  From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis

Secondary Outcomes (3)

• 2

  Day 5 after posaconazole administration, and Days 1, 3, and 7 after the onset of gastrointestinal GVHD

• 3

  From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.

• 4

  From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.

Study Arms (1)

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.

Drug: Posaconazole tablet

Interventions

Posaconazole tablet DRUG

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.

Posaconazole tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patient undergoing Hematopoietic stem cell transplantation who meet the inclusion criteria and do not meet the exclusion criteria can enroll in this study. 2. Ages eligible for study: 18-75 3. Sexes eligible for study: All 4. Race: Chinese 5. Ethnicity: All

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Invasive Fungal Infections; Graft vs Host Disease

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Immune System Diseases

Study Officials

• Aiming Pang, doctor

  Hematopoietic stem cell transplantation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 100 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 20, 2024
• Study Start: August 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)