Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Int… (NCT06183242) | Clinical Trial Compass
CompletedPhase 2/3
Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
Russia328 participantsStarted 2023-05-27
Plain-language summary
Chronic diffuse liver disease implies liver damage of various origin - viral hepatitis, the effect of xenobiotics (alcohol, drugs, medications, industrial toxins), metabolic disorders, non-alcoholic fatty liver disease. Intrahepatic cholestasis syndrome, or bile retention, occurs in 11-55% of cases of diffuse chronic liver diseases, usually leads to a worsening of the liver disease, a decrease in the effectiveness of treatment. The drug REMAXOL® is a solution for infusion, which has shown high effectiveness in the syndrome of intrahepatic cholestasis in cases of liver dysfunction due to acute or chronic damage. The study drug REMAXA® enteric-coated tablets is a hybrid drug which contains the same active metabolites as REMAXOL, i.e. inosine, methionine, nicotinamide, and succinic acid. The purpose of this study is to select the optimal dose and dosage regimen followed by evaluation safety and efficacy of REMAXA®, enteric-coated tablets, in comparison with REMAXOL®, solution for infusion, in patients who suffer from chronic diffuse liver diseases and have intrahepatic cholestasis.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
âś“. Men and women aged 18 to 70 years (inclusive).
âś“. Patients with intrahepatic cholestasis syndrome in chronic diffuse liver diseases (alcoholic liver disease, toxic damage liver, liver fibrosis and sclerosis, fatty liver degeneration, chronic hepatitis) and/or with other liver dysfunction due to acute or chronic damage (toxic, alcoholic, viral, drug hepatitis).
âś“. Gamma-glutamyl transpeptidase (GGTP) exceeds the upper normal limit by 3 times or more and/or alkaline phosphatase (ALP) exceeds the upper normal limit by 1.5 times or more.
âś“. Negative pregnancy test in female patients.
âś“. Consent to the use of adequate contraceptive methods or complete abstinence from sexual activity for the study period.
âś“. Agreement to limit alcohol consumption to a maximum of 2 units alcohol per month (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of dry wine or 50 ml strong alcoholic drinks), or complete abstinence from drinking alcohol for period of the study.
âś“. Signed informed consent.
Exclusion criteria
What they're measuring
1
Proportion of responders to treatment in the study groups
Timeframe: 11 days
Trial details
NCT IDNCT06183242
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
. Cirrhotic stage of chronic liver disease (Class A-C by Child-Pugh).
✕. Hyperbilirubinemia more than 100 µmol/l.
âś•. GGTP level is more than 10 upper normal limits.
âś•. History of autoimmune liver disease.
âś•. Acute viral hepatitis (B, C, D).
âś•. Any somatic diseases in the stage of decompensation.
âś•. Regular use by the patient of medications prohibited in within the framework of this study, within 4 weeks before inclusion in the study and at throughout this study.
âś•. Hypersensitivity and/or intolerance to any component of the study drug /comparator drug.