Who is sponsoring NCT04679103?

NCT04679103 is sponsored by AO GENERIUM.

What drugs are being tested in NCT04679103?

Interventions in NCT04679103: Eculizumab (JSC GENERIUM, Russia).

What condition does NCT04679103 study?

NCT04679103 studies Paroxysmal Nocturnal Hemoglobinuria.

Is NCT04679103 still recruiting?

NCT04679103 is currently completed. Last updated 28 December 2020.

Last reviewed 2020-12-28 · How we verify

NCT04679103: NAP

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

A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation)

Completed Phase 3 Last updated 28 December 2020

What this trial tests

Phase 3 trial testing Eculizumab (JSC GENERIUM, Russia) in Paroxysmal Nocturnal Hemoglobinuria in 50 participants. Completed in 20 April 2020.

Timeline

3 May 2018

Primary endpoint
20 April 2020

20 April 2020

Quick facts

Lead sponsor	AO GENERIUM
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	3 May 2018
Primary completion	20 April 2020
Estimated completion	20 April 2020
Sites	9 locations across Russia

Drugs / interventions tested

Eculizumab (JSC GENERIUM, Russia) — full drug profile →

Conditions studied

Paroxysmal Nocturnal Hemoglobinuria — all drugs for Paroxysmal Nocturnal Hemoglobinuria →

Sponsor

AO GENERIUM — full company profile →

Who can join

Adults 18 to 75, any sex, with Paroxysmal Nocturnal Hemoglobinuria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A safety and immunogenicity study in long-term treatment of Eculizumab (JSC "GENERIUM", Russian Federation) in patients with paroxysmal nocturnal hemoglobinuria, who have been involved earlier in the clinical trials of Eculizumab (JSC "GENERIUM", Russian Federation).

Publications & conference data

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

Results of Long-Term Therapy with a Biosimilar of Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria.
Kulagin AD, Ptushkin VV, Lukina EA, Davydkin IL, et al · · 2025 · cited 3× · PMID 39586236 · DOI 10.1159/000542294

Verify or expand the search:

Other recruiting trials for Paroxysmal Nocturnal Hemoglobinuria

Currently open trials in the same condition.

NCT07457151 — Danicopan PMS in Korea · recruiting
NCT07154745 — A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hem · Phase 3 · recruiting
NCT07470762 — Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 1, PHASE2 · recruiting
NCT07413250 — Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis o · active not recruiting
NCT07413679 — Long-term Safety of Danicopan: IPIG Registry-based Cohort Study · active not recruiting

Other AO GENERIUM trials

Trials by the same sponsor.

NCT07155499 — A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which · Phase 1, PHASE2 · active not recruiting
NCT06488521 — A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers · Phase 1 · active not recruiting
NCT06497491 — An Efficacy and Safety Study of GNR-086 (Canakinumab Biosimilar) and Ilaris® in Patients With Adult-onset Still's Di · Phase 3 · completed
NCT06488664 — An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate · Phase 3 · active not recruiting
NCT06475404 — A Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers · Phase 1 · completed

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 NCT04679103 (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 AO GENERIUM
Last refreshed: 28 December 2020

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/NCT04679103.

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