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

July 5, 2020 updated by: Cinnagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

654

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving various tumor types and regimens with chemotherapy regimens of high FN risk, will be included.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cinnagen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2016

Primary Completion (Actual)

September 7, 2019

Study Completion (Actual)

September 7, 2019

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

July 5, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGAGEN.CIN.AJ.95 (IV)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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