drugset / Trial / NCT04466137

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

NCT04466137

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-10-16
Primary completion
2021-06-24
Completion
2021-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegfilgrastim Protein / enzyme biologic 6 mg
Subject Telpegfilgrastim Protein / enzyme biologic 33 ug/kg Subcutaneous
Subject Telpegfilgrastim Protein / enzyme biologic 2 mg Subcutaneous
Subject filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications