Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy (NCT05789797) | Clinical Trial Compass
CompletedNot Applicable
Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy
Russia368 participantsStarted 2022-05-12
Plain-language 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. Cases of acute drug-induced hepatitis (ADIH) make 15-20 % of patients with fulminant hepatitis in Western Europe.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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:
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
Timeframe: Baseline, up to 15 days
2
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).
Timeframe: Baseline, up to 15 days
Trial details
NCT IDNCT05789797
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
. 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.
. 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.