Serum pharmacokinetics of Caspofungin in patients with liver failure.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004031-23-BE

Enrollment

Registered

2013-02-20

Start date

2014-08-26

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

The patient admitted for alcoholic hepatitis or decompensated cirrhosis (Child-Pugh score of 10-15) presenting with invasive aspergillosis (proven or probable) and treated by caspofungin. MedDRA version: 14.1 Level: LLT Classification code 10024678 Term: Liver failure System Organ Class: 100000004871

Interventions

Trade Name: Cancidas Product Name: Cancidas Pharmaceutical Form: Powder for solution for injection CAS Number: 179463-17-3 Other descriptive name: CASPOFUNGIN ACETATE Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All successive patients with liver failure due to alcoholic hepatitis or decompensated cirrhosis admitted in the hospital will be included. The inclusion criteria for patients with alcoholic hepatitis are 1. age of 18 or older 2. average alcohol intake of more than 50g per day during the 3 months before enrolment 3. a Madrey’s discriminant function of 32 or more 4. a liver biopsy consistent with alcoholic hepatitis (Mallory bodies surrounded by polymorphonuclear neutrophils) The Child-Pugh score will determine the inclusion criteria for liver cirrhosis: patient will be included if the score is between 10 and 15 (score C) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: -Patients with cachexia (Body mass index < 15kg/m²) -Pregnant women

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the 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 C in order to better characterize PK parameters in case of moderate and severe liver dysfunction.;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Measure

Time frame

Main Objective: The objective of the 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 C in order to better characterize PK parameters in case of moderate and severe liver dysfunction.;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium

Contacts

Public ContactFrederique Jacobs

Hopital Erasme

frederique.jacobs@erasme.ulb.ac.be003225554433

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026