{"entity":{"id":"nct04174599","kind":"trial","name":"Study to Compare the Efficacy and Safety of F-627 and GRAN®","aka":[],"tldr":"A phase 3 trial of Efbemalenograstim alfa and Filgrastim in Breast cancer, run by EVIVE Biotechnology, completed.","summary":"Study to Compare the Efficacy and Safety of F-627 and GRAN® is a phase 3 interventional study registered as NCT04174599 by EVIVE Biotechnology, with 242 participants recorded, started 2018-04-12 and reaching its primary completion in 2019-01-24. Interventions recorded: F-627, GRAN®. Conditions recorded: Breast Cancer, Neutropenia.\n\nLinked to the drug Efbemalenograstim alfa because the registry names it among its interventions and Breast cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT04174599","url":"https://clinicaltrials.gov/study/NCT04174599"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["efbemalenograstim-alfa","filgrastim"],"companies":["evive-biotech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04174599","phase":"3","setting":"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","sponsor":"EVIVE Biotechnology","started":"2018-04-12","startedType":"actual","yearReported":2025,"enrolled":242,"enrolledBasis":"registry","outcomes":[{"endpoint":"Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1","primary":true,"unit":"days","arms":[{"name":"F-627","n":120,"value":0.68,"note":"SD 1.100; Figures from the ClinicalTrials.gov results section (first posted 2025-04-20), not from a publication"},{"name":"GRAN®","n":119,"value":0.71,"note":"SD 0.967"}],"source":"https://clinicaltrials.gov/study/NCT04174599?tab=results"}]},"route":"/trials/nct04174599/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"drug":[{"id":"efbemalenograstim-alfa","kind":"drug","name":"Efbemalenograstim alfa","route":"/drugs/efbemalenograstim-alfa/"},{"id":"filgrastim","kind":"drug","name":"Filgrastim (G-CSF)","route":"/drugs/filgrastim/"}],"company":[{"id":"evive-biotech","kind":"company","name":"Evive Biotech","route":"/companies/evive-biotech/"}]}}