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Therapeutic drug monitoring of posaconazole enteric-coated Tablets in patients with liver failure or multiple organ (including liver) failure and optimization of dosing regimen

Therapeutic drug monitoring of posaconazole enteric-coated Tablets in patients with liver failure or multiple organ (including liver) failure and optimization of dosing regimen

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200063000
Enrollment
Unknown
Registered
2022-08-27
Start date
2023-10-23
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal infection

Interventions

Posconazole treatment group:None

Sponsors

The First Affiliated Hospital of Medical College Xi'an jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary test, the patient or his authorized client agree to participate in the clinical trial and sign the informed consent form; 2. Aged >= 13 years, gender is not limited; 3. Patients enrolled should meet the three following criteria at the same time: (1) Liver failure criteria: 1) The diagnostic criteria in the 2018 Chinese Guideline for diagnosis and treatment of liver failure: a) Patients with pre-liver failure stage, specific symptoms include extreme fatigue, and severe gastrointestinal symptoms such as obvious anorexia, vomiting and abdominal distension; b) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased significantly, and jaundice was progressive Deepen (85.5=17.1 µmol/L; c) Hemorrhage tendency, 40% < PTA <= 50%(INR<1.5). 2) patients with moderate or severe degree of liver impairment using Child-Pugh scoring system; (2) Neutrophil count<1.0*10^9/L; (3) patients after liver transplantation or patients with decompensated liver cirrhosis; 4. Using posaconazole enteric-coated tablets to prevent fungal infection and at least 2 times posaconazole blood concentration monitoring; 5. Contraception or no possibility of pregnancy.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to posaconazole enteric-coated tablets; 2. Patients who cannot eat; 3. Pregnancy / breastfeeding; 4. Expected survival time <72 hours; 5. History of drug abuse or alcohol dependence; 6. Any predictable increase in patient risk or other factors that can interfere with clinical trial outcomes.

Design outcomes

Primary

MeasureTime frame
Plasma concentration;

Secondary

MeasureTime frame
Posaconazole adjusted dose and plasma concentration;

Countries

China

Contacts

Public ContactChen Tianyan

The First Affiliated Hospital of Medical College Xi'an Jiaotong University,277 West Yanta Road, Xi'an, Shaanxi

chentianyan@126.com+86 189 9123 2530

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 19, 2026