NCT04460079

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 654 (actual)
• Sponsor: Cinnagen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
DRUG	Peg-filgrastim	PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy

Timeline

• Start date: 2016-03-29
• Primary completion: 2019-09-07
• Completion: 2019-09-07
• First posted: 2020-07-07
• Last updated: 2020-07-07