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Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968395
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

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
Bacterial Infections and Mycoses Liver Disease 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 21, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Caspofungin 70 mg
Infusion of one dose of Caspofungin 70 mg
Drug: Caspofungin 70 mg
Intravenous use
Other Name: Cancidas




Primary Outcome Measures :
  1. Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver failure Child-Pugh B and C

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968395


Locations
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Belgium
Erasme University Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Principal Investigator: Frédérique JACOBS, MD,PhD Erasme University Hospital

Publications of Results:
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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT01968395    
Other Study ID Numbers: E2013_PK_CASPO70_LIVERFAILURE
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: June 2018
Additional relevant MeSH terms:
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Mycoses
Bacterial Infections
Liver Diseases
Liver Failure
Digestive System Diseases
Hepatic Insufficiency
Caspofungin
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action