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

NCT05789797 | Completed

• 1 other identifier: Remaxol\2022\03
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cancer; Drug Induced Liver Injury

Keywords

cancer; drug induced liver injury; remaxol

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

  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.

  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.

  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.

  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.

  Baseline, up to 28 days

Study Arms (2)

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

Drug: Remaxol

Interventions

Remaxol DRUG

Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days

The test group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients with drug-induced liver injuries, during antitumor therapy

You may qualify if:

• 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.);
• Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);
• Antitumor antibiotics (Doxorubicin, Bleomycin etc.);
• Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);
• Topoisomerase inhibitors (Irinotecan, Etoposide etc.).
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• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (5)

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

Krasnoyarsk, Russia

Location

North-West Center of Evidence-Based Medicine

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Republican Clinical Cancer Centre

Ufa, Russia

Location

MeSH Terms

Conditions

Neoplasms; Chemical and Drug Induced Liver Injury

Interventions

Remaxol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: May 12, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 16, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)