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In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDNA

In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis

NCT03337945•University Hospital, Basel, Switzerland

Summary

Subjects will receive the "Basel phenotyping cocktail" capsule orally with 120-200ml tap water in fasted state. After intake peripheral venous blood samples will be drawn. 12 patients (male and female) with liver cirrhosis for each Child Pugh Category A, B, and C, and 12 age- and gender-matched healthy control subjects will be included (in total 48 participants).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Full mental and legal capacity.
•Signed informed consent prior to any study related procedure.
•Ability to communicate in German, sufficient to comprehend and adhere to study protocol.
•Normal physical examination, vital signs, laboratory workup, and CombiCaps LC Study Protocol Version 1.2 09.08.2017 Page 9 of 50 electrocardiogram (ECG) (in the opinion of investigator).
•Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening (in the opinion of investigator).
•No other conditions or circumstances that might interfere with compliance with study protocol (in the opinion of investigator).

Exclusion Criteria

•Known hypersensitivity to probe substances or any excipient of the drug formulation.
•Ongoing or past treatment with another investigational drug within 30 days prior to screening.
•Concomitant treatment with drugs that inhibit or induce CYP3A4, CYP2D6, CYP2C9, CYP2C19, CYP2B6 and CYP1A2 function (in the opinion of investigator).
•Actual infection
•Severe heart failure (NYHA IV).
•Actual alcohol or drug abuse
•Positive results from urine drug screen at screening.
•Excessive caffeine consumption, defined as \>800 mg per day at screening\*.
•Subjects unwilling to stop consumption of alcoholic- and caffeine-containing beverages on study days until after the last sampling time-point of the study period.
•Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450 (e.g. grapefruit juice)
+4 more criteria

Locations (1)

Ambulantes Studienzentrum, Universitätsspital Basel

Basel, Switzerland

Key Dates

Start Date

April 4, 2018

Primary Completion Date

June 30, 2021

Completion Date

December 31, 2021

Last Updated

May 23, 2022

Enrollment

ACTUAL participants

Conditions

Liver Cirrhosis

Interventions

"Basel phenotyping cocktail" capsule

DRUG

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

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Liver CirrhosisLiver Transplant; Complications

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RECRUITING

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis

Inclusion Criteria

Exclusion Criteria

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

DOAC in Patients with Child a or B Liver Cirrhosis

Role of Nutritional Intervention for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome