CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
empegfilrastim +1 morebiological
Likely dose
empegfilrastim 3 mgfrom 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/NCT01569087
NCT01569087Phase 2Completed
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Randomized Multicenter Open-label Phase II Clinical Study Comparing the Efficacy and Safety of the Single Dose of Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

Biocad·interventional·Posted Apr 2, 2012·Updated Dec 5, 2016

In Brief

A Phase 2 clinical trial evaluating empegfilrastim and filgrastim for Chemotherapy-induced Neutropenia. Completed, enrolled 60 participants across 5 sites.

Detailed Summary

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastimt a dose of 3 or 6 mg versus daily administration of filgrastim at a dose of 5 μg/kg/day.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChemotherapy-induced Neutropenia
CountriesRussia
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2012
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2013
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.3 years ago

Interventions

empegfilrastimbiological

Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.

filgrastimbiological

Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.