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

Generium

Status and phase: Completed; Phase 3

Conditions: Idiopathic Thrombocytopenic Purpura

Treatments: Biological: GNR-069

Study type: Interventional

Funder types: Industry

Identifiers

NCT05492409

RMP-ITP-III-X

Details and patient eligibility

About

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

Full description

It is an extension study in patients with ITP who completed participation in RMP-ITP-III clinical trial.

The study will be conducted in three stages:

• Transition visit - 1 day (transition of clinical trial participants from the RMP-ITP-III study to the RMP-ITP-III-X study);
• Treatment period - minimum 26 weeks;
• Follow-up period - 1 week. Patients will then be provided with the study therapy till the product market access with only safety data collection.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

GNR-069

Experimental group

Description:

Weekly subcutaneous injections of GNR-069 in the individually titrated dose.

Treatment:

Biological: GNR-069