Status:
ACTIVE_NOT_RECRUITING
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
Lead Sponsor:
Geropharm
Collaborating Sponsors:
Pharm-Holding
I.M. Sechenov First Moscow State Medical University
Conditions:
Drug Effect
Safety Issues
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ma...
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 w...
Eligibility Criteria
Inclusion
- 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;
- 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.
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
April 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06497036
Start Date
April 4 2023
End Date
March 31 2028
Last Update
July 11 2024
Active Locations (6)
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1
Kaluga Regional Clinical Hospital
Kaluga, Russia, 248007
2
City Clinical Hospital S.P. Botkin of the Moscow City Health Department
Moscow, Russia, 125284
3
National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation
Saint Petersburg, Russia, 194156
4
Samara State Medical University" of the Ministry of Health of the Russian Federation
Samara, Russia, 443099