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

AO GENERIUM160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Idiopathic Thrombocytopenic Purpura

Interventions

GNR-069BIOLOGICAL

Once a week as a subcutaneous injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (13)

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation

Ufa, Bashkortostan Republic, Russia

Outcomes

Primary Outcomes

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

Adverse events will be assessed based on complaints, physical examination and laboratory data.

Time frame: up to 29 weeks

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

The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.

Time frame: up to 29 weeks

Number of clinically significant bleeding on Visits 1-5

The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.

Time frame: up to 29 weeks

Number and proportion of the patient with antidrug antibodies.

The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.

Time frame: up to 29 weeks

Secondary Outcomes

Frequency of the loss of the treatment response

Loss of the treatment response is assessed as absense of platelet increase ≥ 50,0 х 109/L on the 4 weeks treatment with maximal study drug dose.

Time frame: up to 27 weeks

Platelet count dynamics at Visits 1-5

The platalets must be counted till week 5

Time frame: up to 5 weeks

Сhange in ITP-BAT bleeding scores from baseline to week 27

ITP-specific bleeding assessment tool (ITP-BAT) will be calculated at baseline and at week 27.

Time frame: up to 27 weeks

Data from ClinicalTrials.gov

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