NCT03701841

Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary vs Secondary Prophylaxis

Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.

Detailed description

Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.

Conditions

• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
DRUG	PEG-rhG-CSF	All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-10-10
• Last updated: 2018-10-10

Locations

1 site across 1 country: China