NCT02104830 is a Phase 3 clinical trial of Empegfilrastim 6 mg in Chemotherapy-induced Neutropenia, sponsored by Biocad.

Who is sponsoring NCT02104830?

NCT02104830 is sponsored by Biocad.

What drugs are being tested in NCT02104830?

Interventions in NCT02104830: Empegfilrastim 6 mg, Filgrastim, Placebo №1, Placebo №2, Empegfilrastim 7.5 mg.

What condition does NCT02104830 study?

NCT02104830 studies Chemotherapy-induced Neutropenia.

Is NCT02104830 still recruiting?

NCT02104830 is currently completed. Last updated 31 August 2016.

Are results published for NCT02104830?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-08-31 · How we verify

NCT02104830

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicenter Randomized Double-blind Phase III Clinical Study Comparing the Efficacy and Safety of a Single Dose Extimia® Versus Daily Filgrastim for Neutropenia Prophylaxis in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy

Completed Phase 3 Results posted Last updated 31 August 2016

What this trial tests

Phase 3 trial testing Empegfilrastim 6 mg in Chemotherapy-induced Neutropenia in 135 participants. Completed in 1 October 2014.

Timeline

1 September 2013

Primary endpoint
1 June 2014

1 October 2014

Quick facts

Lead sponsor	Biocad
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	135
Start date	1 September 2013
Primary completion	1 June 2014
Estimated completion	1 October 2014
Sites	13 locations across Russia

Drugs / interventions tested

Empegfilrastim 6 mg — full drug profile →
Filgrastim — full drug profile →
Placebo №1
Placebo №2
Empegfilrastim 7.5 mg — full drug profile →

Conditions studied

Chemotherapy-induced Neutropenia — all drugs for Chemotherapy-induced Neutropenia →

Sponsor

Biocad — full company profile →

Who can join

Adults 18 to 70, female only, with Chemotherapy-induced Neutropenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Duration of Neutropenia CTCAE Grade 4
Time frame: 3 weeks
The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).

Sponsor's own description

The purpose of the study is to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Machine learning and bioinformatic analyses link the cell surface receptor transcript levels to the drug response of breast cancer cells and drug off-target effects.
Sinkala M, Naran K, Ramamurthy D, Mungra N, et al · · 2024 · cited 2× · PMID 38306344 · DOI 10.1371/journal.pone.0296511

Verify or expand the search:

Other recruiting trials for Chemotherapy-induced Neutropenia

Currently open trials in the same condition.

NCT06809101 — Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Bal · recruiting
NCT06537726 — Breath Analysis for the Detection of Invasive Fungal Infections · recruiting
NCT07096479 — Telpegfilgrastim Injection to Reduce the Risk of Neutropenia in Patients With Solid Tumor · recruiting
NCT05245487 — Danish Elder Lymphoma Patient Hematopoietic Investigation · recruiting

Other Biocad trials

Trials by the same sponsor.

NCT07136389 — Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus · Phase 1 · recruiting
NCT05974969 — A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subject · Phase 1 · completed
NCT05802225 — Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer · Phase 3 · active not recruiting
NCT05726630 — Clinical Study of Divozilimab in Patients With Systemic Scleroderma · Phase 3 · active not recruiting
NCT05738993 — A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single I · Phase 1 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02104830 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biocad
Last refreshed: 31 August 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02104830.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing