Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Free University of Brussels (ULB)

Status and phase: Completed; Phase 4

Conditions: Bacterial Infections and Mycoses; Liver Disease

Treatments: Drug: Caspofungin 70 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01968395

E2013_PK_CASPO70_LIVERFAILURE

Details and patient eligibility

About

The objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.

Full description

patients admitted for alcoholic hepatitis or decompensated cirrhosis and Child-Pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver failure Child-Pugh B and C

Exclusion criteria

• Cachexia (BMI < 15 kg/m²)
• Pregnancy
• HIV
• Hepatitis C patients

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Caspofungin 70 mg

Other group

Description:

Infusion of one dose of Caspofungin 70 mg

Treatment:

Drug: Caspofungin 70 mg