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Drug EffectPhase 3NCT06497036

Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

A Phase 3 study testing GP404141 and Nplate in people with Drug Effect and Safety Issues, run by Geropharm at 6 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1. Assess the effectiveness of GP40141 in comparison with Nplate®. 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drug Effect, Safety Issues, Immunogenicity
What is being tested?
GP404141 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
6 sitesRussia
Study dates
4 Apr 2023to 31 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent to participate in the study.
  • male or female
  • Age ≥18 years
  • Diagnosis of primary immune thrombocytopenia (PIT).
  • Duration of PIT at the Screening Visit: for cohort 1: ≥3 months; for cohort 2: ≥6 months.
  • PIT therapy with glucocorticosteroids (GCS) for cohort 1: duration of continuous therapy ≥3 months at the Screening Visit or ≥2 courses of pulse therapy during the year before the Screening Visit;
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  • TPO-RA therapy: for cohort 1: no history of TPO-RA use; for Cohort 2: Use of TPO-RA for ≥12 weeks at the Screening Visit;
  • No increase in TPO-RA dose during the 4 weeks preceding the end of screening.
  • Blood platelet count: for cohort 1: mean platelet count ≤30×10*9/L, based on the last two measurements 7±2 days apart, each of which had a platelet count ≤35×10*9/L OR steroid dependence, defined as the use of prednisolone at a daily dose of >5 mg (or another corticosteroid at an equivalent dose) for ≥2 months before the Screening Visit to maintain a platelet count ≥30×10*9/L OR to prevent bleeding; for cohort 2: platelet count ≥50×10*9/ml for ≥6 weeks out of the last 8 weeks of follow-up with platelet counts every 7±2 days and no emergency treatment for severe hemorrhagic syndrome in the last 12 weeks before the Screening Visit.
  • Consent and ability to comply with the procedures of the Protocol, as well as the prohibitions and restrictions provided for by the Research Protocol.

Who cannot join

  • Hypersensitivity to romiplostim.
  • History of TPO-RA use: for cohort 1: any TPO-RA; for cohort 2: any TPO-RA, with the exception of romiplostim and eltrombopag.
  • Unpromising treatment with romiplostim in the opinion of the Researcher
  • Splenectomy <24 weeks prior to the Screening Visit or planned splenectomy during the study.
  • Treatment with rituximab within the 14 weeks preceding the Screening Visit, or planned treatment with rituximab during the study.
  • Treatment with intravenous immunoglobulin or anti-D immunoglobulin during the 2 weeks preceding the Screening Visit, or planned use during the study.
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  • Therapy with hematopoietic growth factors during the 4 weeks preceding the Screening Visit, or their planned use during the study.
  • Therapy with alkylating chemotherapy drugs during the 8 weeks preceding the Screening Visit, or their planned use during the study.
  • Use of other medicines listed in section 5.3.3. of this study protocol.
  • Participation in a clinical trial of an investigational drug or investigational medical device within 4 weeks or 5 half-lives (whichever is longer) preceding the Screening Visit.
  • Secondary immune thrombocytopenia in the following diseases: autoimmune thyroiditis, systemic lupus erythematosus (SLE), antiphospholipid syndrome (APLS), lymphoproliferative diseases, drug-mediated, viral origin (herpes viruses, HIV, chronic viral hepatitis).
  • Hereditary thrombocytopenia.
  • Diseases of the hematopoietic system accompanied by thrombocytopenia (for example, acute leukemia, aplastic anemia, myelodysplastic syndrome, lymphoproliferative diseases).
  • Metastatic bone marrow lesions.
  • Uncontrolled concomitant diseases of internal organs.
  • Arterial thrombosis (for example, myocardial infarction, acute cerebrovascular accident) within 1 year preceding the Screening Visit.
  • History of venous thrombosis.
  • High risk of venous thrombosis and thromboembolism, defined as the presence of at least three of the following risk factors:
  • diabetes;
  • smoking;
  • use of combined oral contraceptives or menopausal hormone therapy;
  • positive titer of antiphospholipid antibodies;
  • hypercholesterolemia (>240 mg/dl or >13 mmol/l);
  • hypertriglyceridemia;
  • arterial hypertension requiring therapy.
  • HIV infection.
  • Viral hepatitis B or C.
  • Oncological and/or oncohematological disease beyond the stage of complete 5-year remission at the Screening Visit.
  • Major surgery ("major surgery") within 8 weeks preceding the Screening Visit, or incomplete recovery from surgery at the Screening Visit.
  • Pregnancy or lactation in women.
  • Hospitalization for any reason planned during the patient's participation in the study.
  • A history of mental disorders that do not allow you to adequately assess your behavior and follow the conditions of the study protocol.
  • Alcoholism. Alcoholism or consumption of alcohol in quantities exceeding for men: 14 units. per week (on average); for women: 7 units. per week (on average).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Russia6 sites

  • Kaluga Regional Clinical Hospital

    Kaluga, 248007

  • City Clinical Hospital S.P. Botkin of the Moscow City Health Department

    Moscow, 125284

  • National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation

    Saint Petersburg, 194156

  • Samara State Medical University" of the Ministry of Health of the Russian Federation

    Samara, 443099

  • Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

    Sochi, 354057

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

    Ufa, 450008

Other trials in Russia

About this study

Official title: Multicenter Randomized Controlled Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) Compared With Nplate® (Amgen, the Netherlands) in Patients With Persistent or Early Immune Thrombocytopenia

The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are

  1. Assess the effectiveness of GP40141 in comparison with Nplate®.
  2. Assess the immunogenicity of GP40141 in comparison with the drug Nplate®.
  3. Assess the safety of GP40141 in comparison with the drug Nplate®.
  4. Assess the safety of changing romiplostim and eltrombopag to GP40141.
  5. Assess the pharmacokinetic parameters of the study drugs in patients with primary immune thrombocytopenia.

Participants divided into 2 cohorts (naïve or treated with a thrombopoietin receptor agonist) will receive romiplostim and platelet response, immune response and adverse reactions will be assessed.

Read the detailed description

The study will be conducted in adult patients with persistent or chronic primary immune thrombocytopenia. Patients both naïve to treatment with a thrombopoietin receptor agonist (cohort 1) and those who have previously received therapy (cohort 2) will be included.

Cohort 1:

Adult steroid-dependent or steroid-refractory patients with persistent or chronic primary immune thrombocytopenia (PIT) with or without a history of splenectomy who have not previously received thrombopoietin receptor agonist (TPO-RA) therapy.

Cohort 2:

Adult patients with persistent or chronic primary immune thrombocytopenia receiving TPO-RA (romiplostim or eltrombopag) for ≥12 weeks and with sustained response status at screening.

Being tested
GP404141, Nplate
Keywords
romiplostim, nplate, bioequivalence

What participants receive

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

  • GP404141Drug

    Also called romiplostim

    subcutaneous injection

  • NplateDrug

    Also called romilostim

    subcutaneous injection

Study groups in NCT06497036
Study groupRoleWhat they receive
GP40141ExperimentalLyophilized powder for solution 250 mcg in vials is diluted in sterile water for injection to a concentration of 500 mcg/ml. Administer once a week. Cohort 1 Starting dose of romiplostim is 1 mcg/kg actual body weight. The weekly dose of romiplostim is increased in increments of 1 mcg/kg body weight until the patient's platelet count reaches ≥50 x 10*9/L. Platelet counts are assessed weekly. Cohort 2 * For subjects receiving Nplate®, a switch to GP40141 at an equivalent dose is recommended 7±2 days after the last Nplate® administration. The transition is equidosal since the drugs contain the same active ingredient. * For patients receiving eltrombopag or Etrombopag-29F® (Pharmproekt, Russia)), it is recommended to switch to GP40141 at an initial dose of 1 mcg/kg the day after the last dose of eltrombopag. The maintenance dose, dose adjustment, and maximum dose are consistent for both cohorts. Duration of therapy with study drugs will be 26 weeks.
Receives: Drug: GP404141
NplateActive comparatorLyophilized powder for solution 250 mcg in vials is diluted in sterile water for injection to a concentration of 500 mcg/ml. Administer once a week. Cohort 1 Starting dose of romiplostim is 1 mcg/kg actual body weight. The weekly dose of romiplostim is increased in increments of 1 mcg/kg body weight until the patient's platelet count reaches ≥50 x 10*9/L. Platelet counts are assessed weekly. Cohort 2 Initial dose: • For patients receiving eltrombopag or Etrombopag-29F® (Pharmproekt, Russia)), it is recommended to switch to at Nplate® initial dose of 1 mcg/kg the day after the last dose of eltrombopag. The maintenance dose, dose adjustment, and maximum dose are consistent for both cohorts. Duration of therapy with study drugs will be 26 weeks.
Receives: Drug: Nplate

What is being measured

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

  1. Proportion of subjects with platelet response

    Blood platelet count ≥50×10*9/L after 10 weeks of therapy (at Visit 11), or blood platelet count ≥200×10*9/L at the last assessment if the study was terminated early.

    Measured: 10 weeks

  2. Number of adverse events (AEs)

    AEs including ones of special interest: bleeding, thrombotic and thromboembolic events.

    Measured: 10 weeks

  3. Proportion of subjects experiencing AEs,

    AEs including ones of special interest: bleeding, thrombotic and thromboembolic events.

    Measured: 10 weeks

  4. Proportion subjects with a immune response to romiplostim

    Proportion of initially immunonaive subjects with a documented immune response to romiplostim at Visits 8 and 26 (weeks 8 and 26).

    Measured: 26 weeks

  5. Proportion subjects with a immune response to endogenous thrombopoietin

    Proportion of initially immunonaive subjects with a documented immune response to endogenous thrombopoietin at Visits 8 and 26 (weeks 8 and 26).

    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 posted11 Jul 2024
  2. Study start4 Apr 2023
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, single-blind, randomized controlled trial of efficacy and safety in two parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06497036
Sponsor's protocol ID
GP40141-P4-03-02
Status last verified
Oct 2023
First submitted
4 Jul 2024
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Melikyan AL, Protsenko EA, Salogub GN, Bakirov BA, Davydkin IL, Kovalik VV, Gefen ML, Matvienko YD, Saparova VB, Khokhlov AL, Makarenko IE, Drai RV. Multicenter Single-Blind Randomized Controlled Trial of the Romiplostim Biosimilar. EJHaem. 2025 Jul 24;6(4):e70105. doi: 10.1002/jha2.70105. eCollection 2025 Aug.

    PubMed 40708707

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP404141 and Nplate in people with Drug Effect and Safety Issues, run by Geropharm at 6 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 10 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

This study is still under way. Results are not available in the source record yet.

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 subjects with platelet response (time frame: 10 weeks). The study lists 5 primary outcomes in all. 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 NCT06497036, which also lists 1 linked publication.

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 11 Jul 2024.

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