MedDataX Logo

Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

NCT ID: NCT01968395

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

NCT01919125

Hepatitis C, Chronic
COMPLETED PHASE1

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001

NCT06619054

Healthy Adults Hepatic Impairment
COMPLETED PHASE1

PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers

NCT02121860

Hepatic Impairment Liver Diseases Digestive System Diseases
COMPLETED PHASE1

A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function

NCT00956306

Hepatic Impairment
COMPLETED PHASE1

A Study to Evaluate the Effect of Hepatic Insufficiency on the Pharmacokinetics (PK) of ACP-196

NCT04867941

Hepatic Insufficiency
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections and Mycoses Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caspofungin 70 mg

Infusion of one dose of Caspofungin 70 mg

Group Type OTHER

Caspofungin 70 mg

Intervention Type DRUG

Intravenous use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caspofungin 70 mg

Intravenous use

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cancidas

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Liver failure Child-Pugh B and C

Exclusion Criteria

* Cachexia (BMI \< 15 kg/m²)
* Pregnancy
* HIV
* Hepatitis C patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frédérique JACOBS, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Erasme University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erasme University Hospital

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 29860319 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E2013_PK_CASPO70_LIVERFAILURE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
NCT04639115 COMPLETED PHASE1
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
NCT01901133 COMPLETED PHASE1
A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
NCT01356550 COMPLETED PHASE1
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
NCT05093972 NOT_YET_RECRUITING PHASE1
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
NCT01298063 COMPLETED PHASE1
Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects
NCT05373953 COMPLETED PHASE1
Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
NCT03529617 RECRUITING
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
NCT04643795 COMPLETED PHASE1
GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
NCT05814926 COMPLETED PHASE1
A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
NCT05610657 COMPLETED PHASE1
Pharmacokinetics Of Orally Administered Fx-1006A In Subjects With Hepatic Dysfunction
NCT01358565 COMPLETED PHASE1
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
NCT01429337 COMPLETED PHASE1
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
NCT05116826 COMPLETED PHASE1
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061 COMPLETED PHASE1
Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
NCT00692341 COMPLETED PHASE1
A Pharmacokinetic Study of MK-3102 in Participants With Impaired Hepatic Function (MK-3102-031)
NCT01767688 COMPLETED PHASE1
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
NCT03562117 COMPLETED PHASE1
Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
NCT01019070 COMPLETED PHASE1
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
NCT06736223 COMPLETED PHASE1
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
NCT02004587 COMPLETED PHASE1
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
NCT03289234 COMPLETED PHASE1
A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function
NCT02005744 COMPLETED PHASE1
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
NCT05537142 COMPLETED PHASE1
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
NCT06568861 COMPLETED PHASE1
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
NCT03824678 COMPLETED PHASE1