Nplate

DRUG4 trials

Sponsors

AO GENERIUM, Geropharm, Nantes University Hospital

Conditions

BioequivalenceChirurgical InterventionDrug EffectIdiopathic Thrombocytopenic PurpuraImmunogenicityPharmacodynamicsPharmacokineticsSafety Issues

Phase 1

Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

GeropharmBioequivalence, Pharmacodynamics, Pharmacokinetics

Start: 2022-06-03End: 2024-09-30Target: 56Updated: 2022-12-15

Phase 2

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

Not yet recruitingNCT07278661

Nantes University HospitalChirurgical Intervention, Thrombocytopaenia

Start: 2026-01-01End: 2028-04-01Target: 136Updated: 2025-12-22

Phase 3

Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

CompletedNCT05220878

AO GENERIUMIdiopathic Thrombocytopenic Purpura

Start: 2021-09-09End: 2023-10-19Updated: 2024-03-06

Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

Active, not recruitingNCT06497036

GeropharmDrug Effect, Immunogenicity, Safety Issues

Start: 2023-04-04End: 2028-03-31Updated: 2024-07-11

Related Papers

Multicenter Single‐Blind Randomized Controlled Trial of the Romiplostim Biosimilar

eJHaem2025-07-241 citations

Population Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim Biosimilar GP40141 and Reference Product in Healthy Volunteers to Evaluate Biosimilarity

Clinical Pharmacology in Drug Development2024-01-031 citations

A randomized, double‐blind, comparative study of the pharmacodynamics and pharmacokinetics of <scp>GP40141</scp> (romiplostim biosimilar) and reference romiplostim in healthy male volunteers

Pharmacology Research & Perspectives2023-09-235 citations