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 range40 Years – 70 Years
SexALL
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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:
✕. 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.
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
✕. 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.