deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04463056

Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH

A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria

Sponsor: AO GENERIUM

Updated 6 times since 2020 Last updated: Aug 27, 2021 Started: Nov 29, 2017 Primary completion: Oct 16, 2018 Completion: Oct 16, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Marchiafava-Micheli Syndrome and Paroxysmal Hemoglobinuria, this trial is completed. The trial is conducted by AO GENERIUM and has accumulated 6 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE3

Show 1 earlier version
  1. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE3

    First recorded

Nov 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AO GENERIUM
Data source: AO GENERIUM

For direct contact, visit the study record on ClinicalTrials.gov .