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Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy | Clinical Trials | Clareo Health

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Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy

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.

NCT05789797•POLYSAN Scientific & Technological Pharmaceutical Company

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. Males and females aged from 40 to 70 years inclusive.
•2. Verified diagnosis of neoplasm (morphologically proven).
•3. Receiving the course polychemotherapy (PCT).
•4. PCT regimens with pronounced hepatotoxic effects, which use drugs from the following pharmacologic classes:
•1. Competitive antagonists (5-Fluorouracil, Methotrexate etc.);
•2. Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
•3. Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
•4. Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
•5. Topoisomerase inhibitors (Irinotecan, Etoposide etc.).
+9 more criteria

Exclusion Criteria

•1. Pregnancy, breast-feeding.
•2. Mental disorders requiring psychiatric observation.
•3. Chronic alcohol abuse and/or substance abuse.
•4. HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases, tuberculosis.
•5. Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCT session immediately preceding this study.
•6. Administration of methionine-, Ademetionine-, malate- and/or succinate-containing medicines during the last month.
•7. Prescription of other malate-, succinate, or methionine-containing medicines (mexidol, cytoflavin, etc.).
•8. 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.
•9. Contraindications mentioned in the approved instructions for use of medicines applied in the study (idiosyncrasy to the product components).
•10. Disease or use of medicines, which, in the doctor's opinion, can influence safety, tolerability and efficiency of the study medicines.

Locations (5)

State Budget-Funded Health Institution Kryzhanovsky Krasnoyarsk Krai Clinical Cancer Centre

Krasnoyarsk, Russia

North-West Center of Evidence-Based Medicine

Saint Petersburg, Russia

Pirogov Clinic of High Medical Technologies, St. Petersburg State University

Saint Petersburg, Russia

St. Petersburg State Budget-Funded Health Institution City Clinical Cancer Centre

Saint Petersburg, Russia

Republican Clinical Cancer Centre

Ufa, Russia

Key Dates

Start Date

May 12, 2022

Primary Completion Date

November 1, 2024

Completion Date

December 16, 2024

Last Updated

August 13, 2025

Enrollment

368

ACTUAL participants

Conditions

CancerDrug Induced Liver Injury

Interventions

Remaxol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Remaxol® in Patients With Drug-induced Liver Injuries During Cancer Chemotherapy

Inclusion Criteria

Exclusion Criteria

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