Status:
COMPLETED
Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Cholestasis, Intrahepatic
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief 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 f...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 70 years (inclusive).
- 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).
- 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.
- Negative pregnancy test in female patients.
- Consent to the use of adequate contraceptive methods or complete abstinence from sexual activity for the study period.
- 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.
- Signed informed consent.
Exclusion
- Cirrhotic stage of chronic liver disease (Class A-C by Child-Pugh).
- Hyperbilirubinemia more than 100 µmol/l.
- GGTP level is more than 10 upper normal limits.
- History of autoimmune liver disease.
- Acute viral hepatitis (B, C, D).
- Any somatic diseases in the stage of decompensation.
- 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.
- Hypersensitivity and/or intolerance to any component of the study drug /comparator drug.
- Pregnancy or lactation period.
- Peptic ulcer of the stomach and/or duodenum, and/or erosive gastritis in the acute phase.
- History of chronic kidney disease C4-C5 and/or known glomerular filtration rate \<30 ml/min.
- Regular intake of more than 2 units. alcohol per week.
- Unstable angina.
- Myocardial infarction 3 months or less before the expected date of inclusion.
- Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
- History of cancer within the last 5 years, mental illness, HIV infection, tuberculosis, drug addiction.
- Mental, physical and other reasons that prevent the patient adequately behave and correctly fulfill the conditions of the study protocol.
Key Trial Info
Start Date :
May 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT06183242
Start Date
May 27 2023
End Date
October 10 2024
Last Update
April 29 2025
Active Locations (3)
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1
Research Center for Eco-safety, Ltd.
Saint Petersburg, Russia, 196143
2
City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, Russia, 197706
3
Medical Company "Hepatologist" Ltd.
Samara, Russia, 443063