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

This is a phase 3 multicenter randomized double-blinded comparative study in collaboration with AP Generium designed to evaluation the clinical safety and efficacy of GNR-069 (a biosimilar to Nplate) vs Nplate in patients with chronic ITP. This study also provides for the evaluation of pharmacokinetic parameters and immunogenicity. Eligibility includes participants with confirmed ITP who are between the ages of 18-75 years.

Russian Federation

https://www.clinicaltrials.gov/ct2/show/NCT05220878?recrs=a&cond=Immune+Thrombocytopenia&draw=2&rank=44#contacts

Recruiting

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