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

NCT05492409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-06-21

No results posted yet for this study

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

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

BIOLOGICAL

GNR-069

Once a week as a subcutaneous injection.

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD, MSc · AO GENERIUM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2024-04-03
Completion
2024-04-03

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05492409 on ClinicalTrials.gov