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Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

NCT05220878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-03-06

No results posted yet for this study

Summary

It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

BIOLOGICAL

GNR-069

Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.

BIOLOGICAL

Nplate

Once a week as a subcutaneous injection. The initial dose is 1 mcg/kg.

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2023-08-22
Completion
2023-10-19

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 NCT05220878 on ClinicalTrials.gov