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

Sponsor

Cinnagen (Industry)

Overall Status

Completed

CT.gov ID

NCT04460079

Collaborator

(none)

654

Enrollment

41.3

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Neutropenia	Drug: Peg-filgrastim

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 Design

Study Type:

Observational

Actual Enrollment :

654 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 29, 2016

Actual Primary Completion Date :

Sep 7, 2019

Actual Study Completion Date :

Sep 7, 2019

Outcome Measures

Primary Outcome Measures

Safety assessment, using incidence according to SOC and PT of AEs and SAEs [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 Outcome Measures

Effectiveness assessment: The frequency of neutropenia and neutropenic fever [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.