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

NCT05601999 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2024-03-06

No results posted yet for this study

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).

Conditions

  • ST Elevation Myocardial Infarction

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

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD, MSc · AO GENERIUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05601999 on ClinicalTrials.gov