Description of the evolution of plasma and urinary concentrations of iohexol in a cirrhotic patient population. Pilot study on 9 patients

Phase 1

• Conditions: Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites; MedDRA version: 20.0 Level: PT Classification code 10019641 Term: Hepatic cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002778-35-FR
• Lead Sponsor: CHU de Limoges

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

1. Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites:
- No ascites: 3 patients.
- Grade 1 (mild): ascites only detectable by ultrasound examination. 3 patients.
- Grade 2 (moderate) and Grade 3 (wide): clinically significant ascites, causing moderate symmetrical distension of the abdomen, or causing severe abdominal distension. 3 patients.
2-3-4. Moreover, patients will be over 18 years, affiliated to a social security scheme and give their informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•Hypersensitivity to the active substance to iodinated contrast agents or any of the excipients listed in section Composition.
•Antecedent of immediate major or cutaneous reaction, delayed to the injection of the iodinated contrast product (Omnipaque).
•Patients with thyrotoxicosis.
•Asthmatic patients.
•Patients with severe cardiovascular disease.
•Patients with central nervous system disorders, especially vascular.
•Patients with pheochromocytoma.
•Patients with myasthenia.
•Patients with sickle cell disease.
•Patients requiring anesthesia on the first day of sampling.
•Patients requiring iodinated contrast injection during hospitalization and in the previous two weeks. Gadolinium injections are not contraindicated.
•Patients under tutorship or curatorship or unable to give informed consent.
•Patients already included in another interventional research protocol or in exclusion period.
•Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified