NCT01569087 is a Phase 2 clinical trial of empegfilrastim in Chemotherapy-induced Neutropenia, sponsored by Biocad.

Who is sponsoring NCT01569087?

NCT01569087 is sponsored by Biocad.

What drugs are being tested in NCT01569087?

Interventions in NCT01569087: empegfilrastim, filgrastim.

What condition does NCT01569087 study?

NCT01569087 studies Chemotherapy-induced Neutropenia.

Is NCT01569087 still recruiting?

NCT01569087 is currently completed. Last updated 24 October 2016.

Are results published for NCT01569087?

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

Last reviewed 2016-10-24 · How we verify

NCT01569087

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

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

Completed Phase 2 Results posted Last updated 24 October 2016

What this trial tests

Phase 2 trial testing empegfilrastim in Chemotherapy-induced Neutropenia in 60 participants. Completed in 1 February 2013.

Timeline

1 May 2012

Primary endpoint
1 January 2013

1 February 2013

Quick facts

Lead sponsor	Biocad
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	60
Start date	1 May 2012
Primary completion	1 January 2013
Estimated completion	1 February 2013
Sites	5 locations across Russia

Drugs / interventions tested

empegfilrastim — full drug profile →
filgrastim — 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.

CTCAE Grade 3/4 Neutropenia Incidence
Time frame: 21 days

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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 NCT01569087 (US National Library of Medicine, public domain)
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: 24 October 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/NCT01569087.

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