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

NCT ID: NCT05220878

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2023-10-19

Brief 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

Detailed Description

The drug GNR-069(JSC "GENERIUM", Russia) is biosimilar to the original drug Nplate. This study is aimed to compare the clinical efficacy and safety of the drug GNR-069 and the drug Nplate to register of the drug GNR-069 in the Russian Federation for therapy in patients with idiopathic thrombocytopenic purpura (ITP). The study also provides for the evaluation of pharmacokinetic parameters and immunogenicity.

Conditions

Idiopathic Thrombocytopenic Purpura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GNR-069

Main group (80 patients) - multiple weekly subcutaneous injections of GNR-069, doses are calculated individually.

Group Type: EXPERIMENTAL

GNR-069

Intervention Type: BIOLOGICAL

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

Nplate

Control group (80 patients) - multiple weekly subcutaneous injections of Nplate, doses are calculated individually.

Group Type: ACTIVE_COMPARATOR

Nplate

Intervention Type: BIOLOGICAL

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

Interventions

GNR-069

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

Intervention Type: BIOLOGICAL

Nplate

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

Intervention Type: BIOLOGICAL

Other Intervention Names

romiplostim; romiplostim

Eligibility Criteria

Inclusion Criteria

1. Written Informed Consent Form to participate in the study;

2. Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;

3. 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;

4. A. For patients who have not had splenectomy:

• established absence/loss of response to therapy with at least one drug of fist-line treatment for ITP (which include GCs an IVIG); OR
• the occurrence of side effects during the course of therapy with the drug of the fist-line, making it impossible to use it further;

B. For patients who underwent splenectomy:

• loss/lack of response to splenectomy;

5. 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;

6. 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;

7. 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

1. Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;

2. Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;

3. Fisher-Evans Syndrome;

4. Conditions with a high risk of thromboembolic complications ;

5. Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;

6. Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;

7. Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);

8. Pregnancy or breastfeeding;

9. Use of drugs:

• romiplostim used less than 3 weeks before treatment with study or reference drug;
• IVIG - less than 2 weeks prior to initiation of study or reference drug therapy;
• eltrombopag - used less than 2 weeks before treatment with study or reference drug, or planned to use eltrombopag while the patient is participating in this study;
• rituximab - used less than 14 weeks before treatment with study or reference drug, or planned to use rituximab while the patient is enrolled in this study;
• cyclophosphamide, cyclosporine, vincristine, vinblastine and other drugs used to treat ITP not listed above and not included in the list of drugs approved for use during the study - use less than 8 weeks before the start of therapy with the study or reference drug or the use of any of these drugs is planned during the patient's participation in this study;
• preparations of any hematopoietic growth factors - use less than 8 weeks before the start of therapy with an investigational or reference drug;
• Influenza vaccines - less than 21 days prior to start of treatment with study or reference drug;
• vaccines to prevent novel coronavirus disease (COVID-19) - completion of the vaccination program less than 21 days prior to the start of study or reference drug therapy;
• other vaccines - less than 8 weeks prior to start of treatment with study or reference drug;

10. Splenectomy within 12 weeks prior to screening;

11. Participation in any clinical trials and/or use of unregistered drugs within 4 weeks prior to screening or 5 drug half-lives (whichever is greater);

12. Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO GENERIUM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oksana A. Markova, MD, MSc

Role: STUDY_CHAIR

AO GENERIUM

Locations

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

State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital

Irkutsk, Irkutsk Oblast, Russia

State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"

Kaluga, Kaluga Oblast, Russia

State Autonomous Healthcare Institution "Kuzbass Clinical Hospital named after S.V. Belyaev"

Kemerovo, Kemerovo Oblast, Russia

State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Llc "Medis"

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

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

Novosibirsk, Novosibirsk Oblast, Russia

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

Rostov-on-Don, Rostov Oblast, Russia

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

Samara, Samara Oblast, Russia

Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation

Saratov, Saratov Oblast, Russia

State Health Institution of the Tula Region "Tula Regional Clinical Hospital"

Tula, Tula Oblast, Russia

State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov" Department of Health of the city of Moscow.

Moscow, , Russia

Federal State Budgetary Institution "National Medical Research Center for Hematology" of the Ministry of Health of the Russian Federation

Moscow, , Russia

State budgetary health care institution of the city of Moscow "Clinical Hospital named after S.P. Botkin" of the Department of Health of the city of Moscow

Moscow, , Russia

State budgetary health care institution of the city of Moscow "City Clinical Hospital named after V.V. Veresaev of the Department of Health of the City of Moscow"

Moscow, , Russia

State Budgetary Health Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"

Moscow, , Russia

Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation

Saint Petersburg, , Russia

Municipal budgetary institution "Central City Hospital No. 7"

Yekaterinburg, , Russia

Countries

Russia

Other Identifiers

№ 407 eff. date 29 July 2021

Identifier Type: OTHER

Identifier Source: secondary_id

RMP-ITP-III

Identifier Type: -

Identifier Source: org_study_id