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COMPLETED
NCT05601999
PHASE3

Study of Efficacy and Safety of GNR-060 vs Metalyse in Patients With ST Elevation Myocardial Infarction

Sponsor: AO GENERIUM

View on ClinicalTrials.gov

Summary

GNR-060(JSC "GENERIUM", Russia) is a proposed biosimilar to the referent product Metalyse. This study is to compare the clinical efficacy and safety of GNR-060 vs Metalyse as a thrombolitic agent in patients with with ST Elevation Myocardial Infarction (STEMI).

Official title: Multicenter Randomized Single Blind Study of the Clinical Efficacy and Safety of GNR-060 (JSC "GENERIUM", Russia) Compared to Metalyse (Boehringer Ingelheim Pharma GmbH & Co.KG, Germany) in Patients With ST Elevation Myocardial Infarction

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2021-09-03

Completion Date

2025-01-15

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

BIOLOGICAL

GNR-060

GNR-060 will be administered in an individual dose depending on body weight as a single intravenous bolus

BIOLOGICAL

Metalyse

Metalyse will be administered in an individual dose depending on body weight as a single intravenous bolus

Locations (11)

Regional State Budgetary Health Institution "Regional Clinical Emergency Hospital"

Barnaul, Altai Territory, Russia

Regional State Budgetary Institution of Health Care "Altai Territorial Cardiology Dispensary"

Barnaul, Altai Territory, Russia

State Budgetary Institution of Health Care of the Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"

Arkhangelsk, Arkhangelskaya oblast, Russia

Regional State Budgetary Health Institution "Belgorod Regional Clinical Hospital of St. Joasaph"

Belgorod, Belgorod Oblast, Russia

State Autonomous Healthcare Institution of the Perm Territory "City Clinical Hospital No. 4"

Perm, Perm Territory, Russia

Municipal budgetary health care institution "City emergency hospital of the city of Rostov-on-Don"

Rostov-on-Don, Rostov Oblast, Russia

State Budgetary Institution of the Ryazan Region "Regional Clinical Hospital"

Ryazan, Ryazan Oblast, Russia

State budgetary health care institution of the Sverdlovsk region "Scientific and practical center for specialized types of medical care" Ural Institute of Cardiology "

Yekaterinburg, Sverdlovsk Oblast, Russia

State Autonomous Healthcare Institution "Interregional Clinical and Diagnostic Center"

Kazan', Tatarstan Republic, Russia

State Health Institution "City Clinical Emergency Hospital No. 25"

Volgograd, Volgograd Oblast, Russia

State Budgetary Health Institution of the Yaroslavl Region "Regional Clinical Hospital"

Yaroslavl, Yaroslavl Oblast, Russia