NCT02005458

Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy

Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia

Conditions

• Non Small Cell Lung Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
DRUG	YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
DRUG	YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
DRUG	PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-03-01
• Completion: 2018-02-01
• First posted: 2013-12-09
• Last updated: 2018-07-17

Locations

12 sites across 1 country: China