NCT04466137

Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy

A Multi-centers, Randomized, Open-labeled, Positive-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF, Once-per-cycle, in Patients With Malignancies Receiving Myelosuppressive Chemotherapy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.

Conditions

• Non-Myeloid Malignancy

Interventions

Type	Name	Description
DRUG	YPEG-rhG-CSF	YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
DRUG	YPEG-rhG-CSF	YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
DRUG	rhG-CSF/PEG-rhG-CSF	rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10\^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.

Timeline

• Start date: 2020-10-16
• Primary completion: 2021-06-24
• Completion: 2021-09-01
• First posted: 2020-07-10
• Last updated: 2022-02-09

Locations

1 site across 1 country: China