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Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced FN

NCT04460079 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 654

Last updated 2020-07-07

No results posted yet for this study

Summary

The present study was an observational, multicenter, non-interventional, single arm, open label, PMS study conducted in Iran.

The primary objective of this study was safety assessment, including the rate of AEs. The secondary objective was the effectiveness evaluation in the prevention of chemotherapy-induced FN.

Conditions

  • Chemotherapy-induced Neutropenia

Interventions

DRUG

Peg-filgrastim

PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Arash Jenabian, Professor · Oncology & Hematology Dep., Booali Hosp., Islamic Azad University, Tehran, Iran

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-29
Primary Completion
2019-09-07
Completion
2019-09-07

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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 NCT04460079 on ClinicalTrials.gov