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Idiopathic Thrombocytopenic PurpuraPhase 3NCT05220878

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

A Phase 3 study testing GNR-069 and Nplate in people with Idiopathic Thrombocytopenic Purpura, run by AO GENERIUM at 18 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Idiopathic Thrombocytopenic Purpura
What is being tested?
GNR-069 and Nplate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
18 sitesRussia
Study dates
9 Sep 2021to 19 Oct 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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;
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  • For patients who underwent splenectomy:
  • loss/lack of response to 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.

Who cannot join

  • 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;
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  • Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
  • Pregnancy or breastfeeding;
  • 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;
  • Splenectomy within 12 weeks prior to screening;
  • 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);
  • Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Russia18 sites

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

    Irkutsk, Irkutsk Oblast, 664079

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

    Kaluga, Kaluga Oblast, 248007

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

    Kemerovo, Kemerovo Oblast, 650066

  • 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, 111123

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

    Moscow, 125167

  • 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, 125284

  • 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, 127644

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

    Moscow, 129110

  • 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, 603126

  • Llc "Medis"

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603137

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

    Novosibirsk, Novosibirsk Oblast, 630091

  • 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, 344022

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

    Saint Petersburg, 197341

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

    Samara, Samara Oblast, 443099

  • 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, 410012

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

    Tula, Tula Oblast, 300053

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

    Ufa, Bashkortostan Republic, 450008

  • Municipal budgetary institution "Central City Hospital No. 7"

    Yekaterinburg, 620137

Other trials in Russia

About this study

Official title: Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura

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

Read the 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.

Being tested
GNR-069, Nplate
Keywords
Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis, Fc-peptide, Recombinant DNA technology, Thrombopoietin receptors, Platelet formation, Fc fragment of human immunoglobulin IgG 1, Low platelet count, ITP treatment, Platelets, Haemorrhage, Platelet destruction, Impaired thrombopoiesis, Megakaryocytes
Medical subject headings
Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia, Hemorrhage, Purpura, Ecchymosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNR-069Biological

    Also called romiplostim

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

  • NplateBiological

    Also called romiplostim

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

Study groups in NCT05220878
Study groupRoleWhat they receive
GNR-069ExperimentalMain group (80 patients) - multiple weekly subcutaneous injections of GNR-069, doses are calculated individually.
Receives: Biological: GNR-069
NplateActive comparatorControl group (80 patients) - multiple weekly subcutaneous injections of Nplate, doses are calculated individually.
Receives: Biological: Nplate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving sustained response to treatment

    A sustained response to treatment is defined as the number of platelets ≥ 50.0 x 109/L for at least 9 out of 12 consecutive visits during the treatment period with the study or reference drug.

    Measured: 26 weeks

Secondary outcomes (7)

  1. Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug

    Stable platelet count is defined as the number of platelets ≥ 50.0 x 109/L for at least 4 consecutive weeks without dose adjustment.

    Measured: 26 weeks

  2. Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count

    Measured: 26 weeks

  3. Number of cases of emergency therapy for severe hemorrhagic syndrome during the treatment period, starting from the second week of therapy with the investigational or reference drug

    Measured: 25 weeks

  4. Number of clinically significant bleeding episodes during the treatment period, starting from the second week of therapy with investigational or reference drug

    Bleeding episode ≥ Grade 2 according to CTCAE version 5.0 is considered clinically significant

    Measured: 26 weeks

  5. Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening

    Measured: 26 weeks

  6. Proportion of patients with no/loss of response to treatment with investigational or reference drug

    Measured: 26 weeks

  7. Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start9 Sep 2021
  3. Primary completion22 Aug 2023
  4. Study completion19 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220878
Sponsor's protocol ID
RMP-ITP-III
Other IDs
№ 407 eff. date 29 July 2021
Status last verified
Mar 2024
First submitted
21 Jan 2022
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GNR-069 and Nplate in people with Idiopathic Thrombocytopenic Purpura, run by AO GENERIUM at 18 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving sustained response to treatment (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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