CompletedPhase 3

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

Russia160 participantsStarted 2021-09-09

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Written Informed Consent Form to participate in the study;
✓. Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;
✓. Documented diagnosis of ITP with a disease duration of more than 12 months from the moment of confirmation of the diagnosis by bone marrow aspirate or biopsy results;
✓. A. For patients who have not had splenectomy:
✓. Thrombocytopenia ≥30.0 x 109/L - \<50.0 x 109/L with severe hemorrhagic syndrome or thrombocytopenia \<30.0 x 109/l, regardless of the presence of hemorrhagic syndrome, according to the results of platelet count conducted in a local laboratory for 7 days before the start of therapy with investigational or reference drug;
✓. Patients receiving GCs, azathioprine and danazole should receive these drugs in a maintenance dose for at least 4 weeks before starting therapy with investigational or reference drug;
✓. Consent of study participants with preserved childbearing function to use reliable methods of contraception (a combination of at least two methods, including 1 barrier method, for example, the use of a condom and spermicide) from the moment of signing the Informed Consent Form and 3 months after the last administration of investigational or reference drug.

Exclusion criteria

✕. Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
✕. Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
✕. Fisher-Evans Syndrome;
✕. Conditions with a high risk of thromboembolic complications ;
✕. Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;
✕. Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;
✕. Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
✕. Pregnancy or breastfeeding;

What they're measuring

Proportion of patients achieving sustained response to treatment

Timeframe: 26 weeks

Trial details

NCT IDNCT05220878

SponsorAO GENERIUM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-22

View on ClinicalTrials.gov More Idiopathic Thrombocytopenic Purpura trials