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A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations

NCT04905329 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 285

Last updated 2021-06-02

No results posted yet for this study

Summary

This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and "Gray Zone" Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

Conditions

Interventions

DRUG

Empegfilgrastim

Extimia®

Sponsors & Collaborators

  • Moscow Clinical Scientific Center

    lead OTHER

Principal Investigators

  • Inna Ganshina, MD, PhD · FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

  • Lyudmila Zhukova, MD, PhD, professor · Moscow Clinical Scientific Center named after AS Loginov

  • Alexey Tryakin, MD, PhD, professor · FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

  • Mikhail Fedyanin, MD, PhD, professor · FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia

  • Svetlana Khokhlova, MD, PhD · FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation

Eligibility

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

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2022-12-31
Completion
2023-09-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04905329 on ClinicalTrials.gov