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Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

Sponsor
Erasme University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01968395
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
13.6
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Caspofungin 70 mg
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Oct 21, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Caspofungin 70 mg

Infusion of one dose of Caspofungin 70 mg

Drug: Caspofungin 70 mg
Intravenous use
Other Names:
  • Cancidas

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure [14 days]

      one dose of caspofungin will be given to patients with hepatic failure. Serum sampling will be performed during 96 hours. Measurements of caspofungin in the serum will be performed to study the pharmacokinetics of this drugs and will be compared with pharmacokinetics of subjects with normal liver function. For safety, patients will be followed during 14 days.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Liver failure Child-Pugh B and C
    Exclusion Criteria:

    • Cachexia (BMI < 15 kg/m²)

    • Pregnancy

    • HIV

    • Hepatitis C patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erasme University Hospital Brussels Belgium 1070

    Sponsors and Collaborators

    • Erasme University Hospital

    Investigators

    • Principal Investigator: Frédérique JACOBS, MD,PhD, Erasme University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Erasme University Hospital
    ClinicalTrials.gov Identifier:
    NCT01968395
    Other Study ID Numbers:
    • E2013_PK_CASPO70_LIVERFAILURE
    First Posted:
    Oct 24, 2013
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Jun 1, 2018
    Additional relevant MeSH terms:
    Mycoses
    Bacterial Infections
    Bacterial Infections and Mycoses
    Liver Diseases
    Liver Failure
    Caspofungin

    Study Results

    No Results Posted as of Feb 15, 2019