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

Chemotherapy-induced Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460079
• Other study ID #: PEGAGEN.CIN.AJ.95 (IV)
• Status: Completed
• Start date: March 29, 2016
• Est. completion date: September 7, 2019

Study information

• Verified date: May 2020
• Source: Cinnagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: September 7, 2019
• Est. primary completion date: September 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• Peg-filgrastim
PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cinnagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment, using incidence according to SOC and PT of AEs and SAEs	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	Effectiveness assessment: The frequency of neutropenia and neutropenic fever	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.