NCT01968395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2014

Completed
Last Updated

February 15, 2019

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

September 25, 2013

Last Update Submit

February 14, 2019

Conditions

Bacterial Infections and MycosesLiver Disease

Outcome Measures

Primary Outcomes (1)

  • Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure

    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.

    14 days

Study Arms (1)

Caspofungin 70 mg

OTHER

Infusion of one dose of Caspofungin 70 mg

Drug: Caspofungin 70 mg

Interventions

Caspofungin 70 mgDRUG

Intravenous use

Also known as: Cancidas
Caspofungin 70 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver failure Child-Pugh B and C

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Related Publications (1)

  • Gustot T, Ter Heine R, Brauns E, Cotton F, Jacobs F, Bruggemann RJ. Caspofungin dosage adjustments are not required for patients with Child-Pugh B or C cirrhosis. J Antimicrob Chemother. 2018 Sep 1;73(9):2493-2496. doi: 10.1093/jac/dky189.

    PMID: 29860319RESULT

MeSH Terms

Conditions

Bacterial Infections and MycosesLiver Diseases

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

InfectionsDigestive System Diseases

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Frédérique JACOBS, MD,PhD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

October 24, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 21, 2014

Last Updated

February 15, 2019

Record last verified: 2018-06

Locations

BE(1)