NCT04174599

Study to Compare the Efficacy and Safety of F-627 and GRAN®

A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of F-627 and GRAN® in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: EVIVE Biotechnology · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

Detailed description

Study Stage: Phase III Study Population: Female patients with breast cancer will be enrolled to receive at least 4 cycles of Epirubicin + Cyclophosphamide (EC) chemotherapy, that is: epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2. Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial

Conditions

• Breast Cancer
• Neutropenia

Interventions

Type	Name	Description
DRUG	F-627	Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy
DRUG	GRAN®	Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)

Timeline

• Start date: 2018-04-12
• Primary completion: 2019-01-24
• Completion: 2019-06-19
• First posted: 2019-11-22
• Last updated: 2025-04-20
• Results posted: 2025-04-20

Locations

1 site across 1 country: China