Trials / Completed
CompletedNCT05789797
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 368 (actual)
- Sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company · Industry
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remaxol | Remaxol®, solution for infusions, by intravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12 days |
Timeline
- Start date
- 2022-05-12
- Primary completion
- 2024-11-01
- Completion
- 2024-12-16
- First posted
- 2023-03-29
- Last updated
- 2025-08-13
Locations
5 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05789797. Inclusion in this directory is not an endorsement.