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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

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