NCT02761460

The Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia

The Study of Evaluating the Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: wang shusen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia

Detailed description

Neutrophilic granulocytopenias is one of the most common and most serious complications in chemotherapy. Research shows that about 25% \~ 40% in patients receiving standard chemotherapy can appear neutropenia with fever. It can increase the risk of infection and Chemotherapy related death, and lead to the delay of chemotherapy, and maybe Reduce the curative effect of chemotherapy. RhG-CSF has widely used to prevent neutropenia, but its half-time is short, and need daily injections to maintain the effective blood drug concentration. Patients are with poor compliance, related adverse reaction and medical costs increase. At the same time, some patients appear neutropenia thought RhG-CSF is given. Therefore, how to reduce the frequency of RhG-CSF injections and more effectively prevent neutropenia more effectively, on the premise of ensure the safety of patients to achieve better effect of chemotherapy, has always been the focus of the clinical problem. Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is a first class national new drug developed by domestic pharmaceutical companies. According to some phase Ⅱand phase Ⅲ clinical trials, PEG-rhG-CSF has a good effect. The patients need only one injection for PEG-rhG-CSF each Cycle of chemotherapy, and the effect of rising white blood cell is more smoothly, and it can avoid pain of repeated injection of PEG-rhG-CSF

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	PEG-rhG-CSF	PEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy

Timeline

• Start date: 2016-05-04
• Primary completion: 2018-04-01
• Completion: 2018-12-01
• First posted: 2016-05-04
• Last updated: 2017-06-01

Locations

1 site across 1 country: China