CompletedPhase 3

Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Russia160 participantsStarted 2022-03-28

Plain-language summary

It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completion of participation in the study RMP-ITP-III while maintaining the clinical effectiveness of romiplostim therapy Exclusion Criteria: * Hypersensitivity to the components of the study drug or E. Coli proteins; * Pregnancy or breastfeeding; * Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study

What they're measuring

Frequency and severity of adverse events associated with the use of the GNR-069

Timeframe: up to 29 weeks

Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)

Timeframe: up to 29 weeks

Number of clinically significant bleeding on Visits 1-5

Timeframe: up to 29 weeks

Number and proportion of the patient with antidrug antibodies.

Timeframe: up to 29 weeks

Trial details

NCT IDNCT05492409

SponsorAO GENERIUM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-03

View on ClinicalTrials.gov More Idiopathic Thrombocytopenic Purpura trials