CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
F-627 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04174599
NCT04174599Phase 3Completed
CompareCT.gov

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

EVIVE Biotechnology·interventional·Posted Nov 22, 2019·Updated Apr 20, 2025

In Brief

A Phase 3 clinical trial evaluating F-627 and GRAN® for Breast Cancer and Neutropenia. Completed, enrolled 242 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Neutropenia
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 22, 2019
Enrollment StartApr 12, 2018
Primary CompletionJan 24, 2019
Study CompletionJun 19, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.6 years ago

Interventions

F-627drug

Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy

GRAN®drug

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®)