drugset / Trial / NCT07146360

Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction

NCT07146360

Phase 3 Completed 180 enrolled AO GENERIUM
RandomizedParallel-groupSingle-blindTreatment

Summary

Thi is is a multi-center, randomized, single-blind, parallel group clinical trial to evaluate the efficacy and safety of the intravenious thrombolysis with Revelise® (GENERIUM, Russia) in comparosin with the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in patients with acute myocardial infarction (MI) with ST-segment elevation on the electrocardiogram (ECG). The thrombolisis was performed within the period of up to 6 hours and from 6 to 12 hours from the MI symptoms onset.

Timeline

Start
2014-05-25
Primary completion
2017-11-21
Completion
2017-12-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alteplase Protein / enzyme biologic 1.5 mg/kg Intravenous
Comparator Alteplase Protein / enzyme biologic 100 mg Intravenous
Subject Revelise Protein / enzyme biologic 1.5 mg/kg Intravenous
Subject Revelise Protein / enzyme biologic 100 mg Intravenous

Indications