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NCT Number: NCT04460079

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

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.

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Key information

Conditions

Chemotherapy-induced Neutropenia Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Data was gathered in two booklets, each containing information on four cycles of chemotherapy, which was filled by the designated physician. The duration of PegaGen® treatment was at the physicians' discretion based on the patient's condition.

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.

This study was single arm and 654 subjects participated across various tumor types and regimens.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years,
  • with the diagnosis of various types of cancers (such as lymphoma, breast, lung, testicular, prostate, ovary and gastrointestinal cancers), receiving first-line chemotherapy regimens with a high FN risk, which PegaGen® is injected due to physician decision.

Treatment and study plan

Peg-filgrastim

Drug

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

Other names: PegaGen®

Primary outcomes

  1. Safety assessment, using incidence according to SOC and PT of AEs and SAEs

    Time frame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.

    Safety evaluation was reported using summary statistics. For each AE, data was summarized using incidence according to system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done and its results was reported by frequency and percentage.

Secondary outcomes

  1. Effectiveness assessment: The frequency of neutropenia and neutropenic fever

    Time frame: This outcome was assessed throughout the study, up to 8 chemotherapy cycles. The duration of treatment was at the physicians' discretion based on the patient's condition.

    The frequency of neutropenia and neutropenic fever was reported

Sponsors and collaborators

Lead sponsor

Cinnagen

Industry

Registry information

Official study title

Safety and Effectiveness Assessment of PeGagen® (Pegfilgrastim) in the Prevention of Chemotherapy-induced Febrile Neutropenia in Iranian Cancer Patients

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2020
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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