An observational study in Cancer and Drug Induced Liver Injury, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Completed at 5 sites in Russia. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Observational
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's enrollment of 368 is above the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →POLYSAN Scientific & Technological Pharmaceutical Company is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cancer patients with drug-induced liver injuries, during antitumor therapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
PCT regimens with pronounced hepatotoxic effects, which use drugs from the following pharmacologic classes:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days
Drug: Remaxol
Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days
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
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
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.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
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.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
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.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
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.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
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).
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.
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.
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
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
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
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
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
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.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
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.
Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Time frame: Baseline, up to 28 days
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Nov 2024, 29 months.
Of 148 industry-sponsored observational studies under Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 102. This study's 29 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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POLYSAN Scientific & Technological Pharmaceutical Company →