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

PHASE3CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

April 12, 2018

Primary Completion Date

January 24, 2019

Study Completion Date

June 19, 2019

Conditions
Breast CancerNeutropenia
Interventions
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®)

Trial Locations (1)

200032

Fudan University Shanghai Cancer Center, Shanghai

Sponsors
All Listed Sponsors
lead

EVIVE Biotechnology

INDUSTRY