Hepatic and Hepatobiliary Disorders Clinical Trial
Official title:
Multicenter Prospective Uncontrolled Non-comparative Open Interventional Clinical Study of Phase III for Assessment of the Safety and Effectiveness of Using the Drug Phosphatidylcholine Paste 600 mg in Patients With Acute and Chronic Liver Diseases and Clinical Symptoms of Dysfunction of the Gastrointestinal Tract During 12-week Therapy Course
Primary Objective:
To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day
for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.
Secondary Objectives:
To assess effectiveness on symptomatic improvement in patients with gastrointestinal
symptoms in acute and chronic liver diseases.
To monitor compliance.
The total study duration per patient will be 13 weeks that consists of 1-week pre-screening period and a 12-week treatment period. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05228587 -
Indocyanine Green Clearance Test in Liver Transplantation (LivInG)
|
N/A |