CancerNCT05789797
Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy
An observational study of Cancer and Drug Induced Liver Injury, run by POLYSAN Scientific & Technological Pharmaceutical Company at 5 sites in Russia.
Trial summary
Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality. 40 % of hepatitis cases in patients older than 40 years and 25 % of cases of fulminant hepatic failure (FHF) are caused by drug hepatic toxicity. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cancer, Drug Induced Liver Injury
- What is being tested?
- Remaxol
- Type of treatment
- Injection or infusion
- How many people
- 368 participants
- Where
- 5 sitesRussia
- Study dates
- 12 May 2022to 16 Dec 2024
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with drug-induced liver injuries, during antitumor therapy
Who may be able to join
- The study can include all patients who are scheduled, at a physician's discretion, to receive the therapy with the drug Remaxol®, solution for infusions, or Ademethionine, lyophilizate for solution for intravenous and intramuscular injection, according to the approved instruction for the medical use of the drug and established clinical practice of a healthcare facility, and who meet all the following criteria:
- Males and females aged from 40 to 70 years inclusive.
- Verified diagnosis of neoplasm (morphologically proven).
- Receiving the course polychemotherapy (PCT).
- PCT regimens with pronounced hepatotoxic effects, which use drugs from the following pharmacologic classes:
- Competitive antagonists (5-Fluorouracil, Methotrexate etc.);
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- Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
- Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
- Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
- Topoisomerase inhibitors (Irinotecan, Etoposide etc.).
- <!-- -->
- Contraindications for the continuation of PCT at the time of a visit to a physician for its continuation, because of developed hepatotoxicity.
- Stage of the treatment: supporting, hepatoprotective and detoxication therapy to correct hepatotoxicity developed during PCT, to remove it and continue the chemotherapeutic treatment.
- A patient is scheduled to receive one of the following infusion therapies with the following regimen, as part of the routine clinical practice:
- It is planned to administer the drug Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days.
- It is planned to administer the drug Ademethionine, lyophilisate for solution for intravenous and intramuscular injection, by intravenous drop infusion in the dose of 800 mg/day, on everyday basis for 14 days. ECOG performance status score: 1-2 inclusive (Karnofsky score: 50-80 %).
- Hepatotoxicity grade according to the classification of the US National Cancer Institute (NCCN, CTC) - 2 and 3.
- Scores by selected parameters of CTCAE (National Cancer Institute Common Toxicity Criteria for Adverse Events) scale - I and II.
- Patient's written consent for participation in the study according to the current legislation.
Who cannot join
- Pregnancy, breast-feeding.
- Mental disorders requiring psychiatric observation.
- Chronic alcohol abuse and/or substance abuse.
- HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases, tuberculosis.
- Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCT session immediately preceding this study.
- Administration of methionine-, Ademetionine-, malate- and/or succinate-containing medicines during the last month.
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- Prescription of other malate-, succinate, or methionine-containing medicines (mexidol, cytoflavin, etc.).
- Decompensation of any severe/clinically apparent somatic diseases of the kidneys, liver, cardiovascular system, respiratory system, endocrine system, etc., as decided by the investigating physician.
- Contraindications mentioned in the approved instructions for use of medicines applied in the study (idiosyncrasy to the product components).
- Disease or use of medicines, which, in the doctor's opinion, can influence safety, tolerability and efficiency of the study medicines.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
State Budget-Funded Health Institution Kryzhanovsky Krasnoyarsk Krai Clinical Cancer Centre
Krasnoyarsk
North-West Center of Evidence-Based Medicine
Saint Petersburg
Pirogov Clinic of High Medical Technologies, St. Petersburg State University
Saint Petersburg
St. Petersburg State Budget-Funded Health Institution City Clinical Cancer Centre
Saint Petersburg
Republican Clinical Cancer Centre
Ufa
About this study
Official title: Non-interventional, Prospective Study of Safety and Efficiency of the Drug Remaxol® (NTFF POLYSAN Ltd., Russia) in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy.
Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality.
40 % of hepatitis cases in patients older than 40 years and 25 % of cases of fulminant hepatic failure (FHF) are caused by drug hepatic toxicity. Cases of acute drug-induced hepatitis (ADIH) make 15-20 % of patients with fulminant hepatitis in Western Europe.
- Conditions
- Cancer, Drug Induced Liver Injury
- Being tested
- Remaxol
- Keywords
- cancer, drug induced liver injury, remaxol
- Medical subject headings
- Neoplasms, Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemaxolDrug
Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days
| Study group | Role | What they receive |
|---|---|---|
| The control group | Ademethionine, lyophilisate for solution for intravenous and intramuscular injection, by intravenous drop infusion in the dose of 800 mg/day, on everyday basis for 14 days | |
| The test group | Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days Receives: Drug: Remaxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of average ALT values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines).
Measured: Baseline, up to 15 days
Difference of average ALP values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines).
Measured: Baseline, up to 15 days
Secondary outcomes (18)
Proportion of patients achieving an ECOG patient status score of 0 from the start of study (Visit1) to Visit 4, measured in both groups
ECOG Scale of Performance Status (Eastern Cooperative Oncology Group) - 0-4 poins 0 points - The patient is fully active, able to perform everything, as before the disease.
4 points - Disabled, completely incapable of self-care, chained to a chair or bed
Measured: Baseline, up to 28 days
Proportion of patients who resumed a PCT session (staged session after a period of study medicines administration) within 28 days of the start of hepatotoxicity correction with study medicines (Visit 1), measured in both groups.
Measured: Baseline, up to 28 days
Proportion of patients who received a staged PCT session in full (no reduction in chemotherapy doses), measured in both groups.
Measured: Baseline, up to 28 days
Proportion of patients with grade 1 of hepatotoxicity according to the CTCAE scale, by at least 3 out of 5 parameters: ALP, ALT, AST, total and direct bilirubin, GGT, from the baseline (Visit 1) to Visit 3, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Baseline, up to 15 days
Proportion of patients with grade 1 of hepatotoxicity according to the CTCAE scale, by at least 3 out of 5 parameters: ALP, ALT, AST, total and direct bilirubin, GGT, from the baseline (Visit 1) to Visit 4, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Baseline, up to 28 days
Proportion of patients with grade 4 of hepatotoxicity according to the US National Cancer Institute (CTCAE) scale, by any of the parameters from the baseline (Visit 1) to Visit 3, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Baseline, up to 15 days
Proportion of patients with grade 4 of hepatotoxicity according to the US National Cancer Institute (CTCAE) scale, by any of the parameters from the baseline (Visit 1) to Visit 4, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Baseline, up to 28 days
Difference of average total scores in A.V. Shaposhnikov hepatotoxicity scale measured in both groups between two time points: Visit 3 vs. baseline at Visit 1 (before the therapy with study medicines).
0 degree = 0-3 points; 1 degree = 3-8 points; 2 degree = 9-14 points; 3rd degree = 15-20 points; 4 degree = 21-25 points.
Measured: Baseline, up to 15 days
ALT changes during the study period (Visit 2, 3, 4)
Measured: Baseline, up to 15 days, up to 28 days
Proportion of patients achieving 90% or more on the Karnofsky scale from the start of the study (Visit 1) to Visit 3, measured in both groups.
the Karnofsky score: 100% - Normal condition, no complaints 90% - Capable of normal activities, minor symptoms or signs of disease 80% - Normal activity with effort, minor symptoms or signs of disease 70% Self-supporting, incapable of normal activities or active work 60% - Sometimes needs help, but is able to satisfy most of his needs. 50% - Needs significant assistance and medical care 40% - Disabled, needs special assistance, including medical 30% - Severe disability, hospitalization is indicated, although death is not directly threatened 20% - Severe patient. Hospitalization and active treatment required 10% - Dying
Measured: Baseline, up to 15 days
Proportion of patients with full normalisation of ALT, AST by 2, 3, 4 Visits, measured in both groups.
Measured: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of ALP by 2, 3, 4 Visits, measured in both groups.
Measured: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of GGT by 2, 3, 4 Visits, measured in both groups.
Measured: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of total and direct bilirubin by 2, 3, 4 Visits, measured in both groups.
Measured: Baseline, up to 7 days, up to 15 days, up to 28 days
Changes in the patient's condition according to the Karnofsky score during the study (Visits 2, 3, 4) compared to the study initiation (Visit 1), expressed as a % of the baseline
the Karnofsky score: 100% - Normal condition, no complaints 90% - Capable of normal activities, minor symptoms or signs of disease 80% - Normal activity with effort, minor symptoms or signs of disease 70% Self-supporting, incapable of normal activities or active work 60% - Sometimes needs help, but is able to satisfy most of his needs. 50% - Needs significant assistance and medical care 40% - Disabled, needs special assistance, including medical 30% - Severe disability, hospitalization is indicated, although death is not directly threatened 20% - Severe patient. Hospitalization and active treatment required 10% - Dying
Measured: Baseline, up to 7 days, up to 15 days, up to 28 days
Changes in the patient's condition according to the ECOG Scale, during the study period (Visits 2, 3, 4) as compared to the study initiation (Visit 1), expressed as a score and as a % of the baseline
ECOG Scale of Performance Status (Eastern Cooperative Oncology Group) - 0-4 poins 0 points - The patient is fully active, able to perform everything, as before the disease.
4 points - Disabled, completely incapable of self-care, chained to a chair or bed
Measured: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with detected toxic damage to at least one system or organ (by selected parameters), according to the criteria of common toxicity grade III of the CTCAE scale, from the baseline (Visit 1) to Visit 3, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Baseline, up to 15 days
Proportion of patients with detected toxic damage to at least one system or organ (by selected parameters), according to the criteria of common toxicity grade III of the CTCAE scale, from the baseline (Visit 1) to Visit 4, measured in both groups.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: Baseline, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start12 May 2022
- Primary completion1 Nov 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789797
- Sponsor's protocol ID
- Remaxol\2022\03
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2023
- Last updated
- 13 Aug 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Prospective Study of Safety and Efficiency of the Drug Remaxol® (NTFF POLYSAN Ltd., Russia) in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy.
- ClinicalTrials.gov ID
- NCT05789797
- Acronym / sponsor ID
- Remaxol\2022\03
- Conditions
- Cancer, Drug Induced Liver Injury
- Keywords
- cancer, drug induced liver injury, remaxol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 29 Mar 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.
Cancer has moved from the tenth place to the second one over the last 100 years, being inferior to only cardiovascular diseases in morbidity and mortality.
40 % of hepatitis cases in patients older than 40 years and 25 % of cases of fulminant hepatic failure (FHF) are caused by drug hepatic toxicity. Cases of acute drug-induced hepatitis (ADIH) make 15-20 % of patients with fulminant hepatitis in Western Europe.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | –Ademethionine, lyophilisate for solution for intravenous and intramuscular injection, by intravenous drop infusion in the dose of 800 mg/day, on everyday basis for 14 days |
| The test group | – | Drug: RemaxolRemaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with drug-induced liver injuries, during antitumor therapy
Key inclusion criteria (19 listed)
- The study can include all patients who are scheduled, at a physician's discretion, to receive the therapy with the drug Remaxol®, solution for infusions, or Ademethionine, lyophilizate for solution for intravenous and intramuscular injection, according to the approved instruction for the medical use of the drug and established clinical practice of a healthcare facility, and who meet all the following criteria:
- <!-- -->
Key exclusion criteria (10 listed)
- Pregnancy, breast-feeding.
- Mental disorders requiring psychiatric observation.
- Chronic alcohol abuse and/or substance abuse.
- HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases, tuberculosis.
- Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCT session immediately preceding this study.
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 |
|---|---|---|
| RemaxolRemaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days | Drug | The test group |
Primary outcome
Difference of average ALT values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines).
Time frame: Baseline, up to 15 days
Difference of average ALP values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines).
Time frame: Baseline, up to 15 days
18 secondary outcomes
Proportion of patients achieving an ECOG patient status score of 0 from the start of study (Visit1) to Visit 4, measured in both groups
Time frame: Baseline, up to 28 days
Proportion of patients who resumed a PCT session (staged session after a period of study medicines administration) within 28 days of the start of hepatotoxicity correction with study medicines (Visit 1), measured in both groups.
Time frame: Baseline, up to 28 days
Proportion of patients who received a staged PCT session in full (no reduction in chemotherapy doses), measured in both groups.
Time frame: Baseline, up to 28 days
Proportion of patients with grade 1 of hepatotoxicity according to the CTCAE scale, by at least 3 out of 5 parameters: ALP, ALT, AST, total and direct bilirubin, GGT, from the baseline (Visit 1) to Visit 3, measured in both groups.
Time frame: Baseline, up to 15 days
Proportion of patients with grade 1 of hepatotoxicity according to the CTCAE scale, by at least 3 out of 5 parameters: ALP, ALT, AST, total and direct bilirubin, GGT, from the baseline (Visit 1) to Visit 4, measured in both groups.
Time frame: Baseline, up to 28 days
Proportion of patients with grade 4 of hepatotoxicity according to the US National Cancer Institute (CTCAE) scale, by any of the parameters from the baseline (Visit 1) to Visit 3, measured in both groups.
Time frame: Baseline, up to 15 days
Proportion of patients with grade 4 of hepatotoxicity according to the US National Cancer Institute (CTCAE) scale, by any of the parameters from the baseline (Visit 1) to Visit 4, measured in both groups.
Time frame: Baseline, up to 28 days
Difference of average total scores in A.V. Shaposhnikov hepatotoxicity scale measured in both groups between two time points: Visit 3 vs. baseline at Visit 1 (before the therapy with study medicines).
Time frame: Baseline, up to 15 days
ALT changes during the study period (Visit 2, 3, 4)
Time frame: Baseline, up to 15 days, up to 28 days
Proportion of patients achieving 90% or more on the Karnofsky scale from the start of the study (Visit 1) to Visit 3, measured in both groups.
Time frame: Baseline, up to 15 days
Proportion of patients with full normalisation of ALT, AST by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of ALP by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of GGT by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with full normalisation of total and direct bilirubin by 2, 3, 4 Visits, measured in both groups.
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Changes in the patient's condition according to the Karnofsky score during the study (Visits 2, 3, 4) compared to the study initiation (Visit 1), expressed as a % of the baseline
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Changes in the patient's condition according to the ECOG Scale, during the study period (Visits 2, 3, 4) as compared to the study initiation (Visit 1), expressed as a score and as a % of the baseline
Time frame: Baseline, up to 7 days, up to 15 days, up to 28 days
Proportion of patients with detected toxic damage to at least one system or organ (by selected parameters), according to the criteria of common toxicity grade III of the CTCAE scale, from the baseline (Visit 1) to Visit 3, measured in both groups.
Time frame: Baseline, up to 15 days
Proportion of patients with detected toxic damage to at least one system or organ (by selected parameters), according to the criteria of common toxicity grade III of the CTCAE scale, from the baseline (Visit 1) to Visit 4, measured in both groups.
Time frame: Baseline, up to 28 days
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 13 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Drug Induced Liver Injury, run by POLYSAN Scientific & Technological Pharmaceutical Company at 5 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 19 inclusion and 10 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Difference of average ALT values in both of the groups, between the two timepoints: Visit 3 vs. baseline at Visit 1 (before starting therapy with the study medicines). (time frame: Baseline, up to 15 days). The study lists 2 primary outcomes in all. 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 13 Aug 2025.