Cholestasis, IntrahepaticPhase 2/3NCT06183242
Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis
A Phase 2/3 study testing Remaxa, enteric-coated tablets and Remaxol in people with Cholestasis, Intrahepatic, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholestasis, Intrahepatic
- What is being tested?
- Remaxa, enteric-coated tablets and Remaxol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 3 sitesRussia
- Study dates
- 27 May 2023to 10 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Research Center for Eco-safety, Ltd.
Saint Petersburg, 196143
City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, 197706
Medical Company "Hepatologist" Ltd.
Samara, 443063
About this study
Official title: Multicenter Comparative Randomized Study to Assess Safety and Efficacy and Select the Optimal Dosage Regimen of REMAXA®, Enteric-coated Tablets, in Comparison With REMAXOL®, Solution for Infusions, in Patients With Intrahepatic Cholestasis Caused by Chronic Diffuse Liver Diseases
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.
- Conditions
- Cholestasis, Intrahepatic
- Being tested
- Remaxa, enteric-coated tablets, Remaxol, Placebo
- Keywords
- intrahepatic cholestasis, chronic diffuse liver disease, Biliary Stasis, Intrahepatic
- Medical subject headings
- Cholestasis, Intrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remaxa, enteric-coated tabletsDrug
Also called inosine, methionine, nicotinamide, succinic acid
enteric-coated tablets
RemaxolDrug
Also called inosine + meglumine + methionine + nicotinamide + succinic acid
solution for infusions
PlaceboDrug
enteric-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Group I-1 | Experimental | Intake of REMAXA, enteric-coated tablets, 2 tablets 3 times a day for 10 days Receives: Drug: Remaxa, enteric-coated tablets |
| Group I-2 | Experimental | Intake of REMAXA, enteric-coated tablets, 2 tablets 2 times a day for 10 days Receives: Drug: Remaxa, enteric-coated tablets |
| Group I-3 | Experimental | Intake of REMAXA, enteric-coated tablets, 2 tablets once a day for 10 days Receives: Drug: Remaxa, enteric-coated tablets |
| Group I-4 | Active comparator | Infusions of REMAXOL, solution for infusion, by intravenous drip, 400 ml once a day for 10 days. Receives: Drug: Remaxol |
| Group II-1 | Experimental | Intake of REMAXA, enteric-coated tablets, during 10 days according to optimal dosing regimen established during stage I. Receives: Drug: Remaxa, enteric-coated tablets |
| Group II-2 | Active comparator | Infusions of REMAXOL, solution for infusion, by intravenous drip, 400 ml once a day for 10 days. Receives: Drug: Remaxol |
| Group II-3 | Placebo comparator | Intake of Placebo, enteric-coated tablets, during 10 days, analogous to dosing regimen in Group II-1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders to treatment in the study groups
The proportion of patients who responded to therapy, as indicated by any of the changes of laboratory parameters: a decrease in the level of gamma-glutamyltranspeptidase by at least 40% from the initial level and/or a decrease in the level of alkaline phosphatase by at least 30% from the initial level and/or a decrease in the level of total bilirubin not by less than 30% from the initial to the end of the therapeutic course in the REMAXA group compared to REMAXOL group.
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start27 May 2023
- Primary completion24 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestasis, IntrahepaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective two-stage comparative randomized parallel group study with placebo control
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana V Kharitonova, MD PhD, Study director, STPF POLYSAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183242
- Sponsor's protocol ID
- RXA-II-III-Chol-2022
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2023
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Comparative Randomized Study to Assess Safety and Efficacy and Select the Optimal Dosage Regimen of REMAXA®, Enteric-coated Tablets, in Comparison With REMAXOL®, Solution for Infusions, in Patients With Intrahepatic Cholestasis Caused by Chronic Diffuse Liver Diseases
- ClinicalTrials.gov ID
- NCT06183242
- Acronym / sponsor ID
- RXA-II-III-Chol-2022
- Conditions
- Cholestasis, Intrahepatic
- Keywords
- intrahepatic cholestasis, chronic diffuse liver disease, Biliary Stasis, Intrahepatic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 May 2023 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 7
- Model description
- Multicenter prospective two-stage comparative randomized parallel group study with placebo control
| Arm | Type | Receives |
|---|---|---|
| Group I-1 | Experimental | Drug: Remaxa, enteric-coated tabletsIntake of REMAXA, enteric-coated tablets, 2 tablets 3 times a day for 10 days |
| Group I-2 | Experimental | Drug: Remaxa, enteric-coated tabletsIntake of REMAXA, enteric-coated tablets, 2 tablets 2 times a day for 10 days |
| Group I-3 | Experimental | Drug: Remaxa, enteric-coated tabletsIntake of REMAXA, enteric-coated tablets, 2 tablets once a day for 10 days |
| Group I-4 | Active comparator | Drug: RemaxolInfusions of REMAXOL, solution for infusion, by intravenous drip, 400 ml once a day for 10 days. |
| Group II-1 | Experimental | Drug: Remaxa, enteric-coated tabletsIntake of REMAXA, enteric-coated tablets, during 10 days according to optimal dosing regimen established during stage I. |
| Group II-2 | Active comparator | Drug: RemaxolInfusions of REMAXOL, solution for infusion, by intravenous drip, 400 ml once a day for 10 days. |
| Group II-3 | Placebo comparator | Drug: PlaceboIntake of Placebo, enteric-coated tablets, during 10 days, analogous to dosing regimen in Group II-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remaxa, enteric-coated tabletsAlso: inosine, methionine, nicotinamide, succinic acidenteric-coated tablets | Drug | Group I-1, Group I-2, Group I-3, Group II-1 |
| RemaxolAlso: inosine + meglumine + methionine + nicotinamide + succinic acidsolution for infusions | Drug | Group I-4, Group II-2 |
| Placeboenteric-coated tablets | Drug | Group II-3 |
Primary outcome
Proportion of responders to treatment in the study groups
Time frame: 11 days
The proportion of patients who responded to therapy, as indicated by any of the changes of laboratory parameters: a decrease in the level of gamma-glutamyltranspeptidase by at least 40% from the initial level and/or a decrease in the level of alkaline phosphatase by at least 30% from the initial level and/or a decrease in the level of total bilirubin not by less than 30% from the initial to the end of the therapeutic course in the REMAXA group compared to REMAXOL group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Cholestasis, Intrahepatic
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Active, not recruitingPhase 2/3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Primary Biliary Cholangitis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
RecruitingPhase 2
Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
Primary Biliary Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana V Kharitonova, MD PhD study director
STPF POLYSAN
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Remaxa, enteric-coated tablets and Remaxol in people with Cholestasis, Intrahepatic, run by POLYSAN Scientific & Technological Pharmaceutical Company at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders to treatment in the study groups (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.