A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP

Официальное название

A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia

Обзор

The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.

Подробное описание

This is a single-arm, prospective clinical study to evaluate the efficacy and safety of herombopag in the treatment of elderly patients with ITP. The study will include 80 patients. Screening of patients will be 2 weeks after the longest period, to enter after the treatment period, accept the herombopag 5 mg, once daily, on an empty stomach, oral medication can be eating only 2 hours, and 24 weeks of treatment, and adjust the dosage according to the platelet count. If patients do not respond to treatment after 8 weeks, it is recommended to withdraw from the study and continue safety visits for 4 weeks. During treatment, the patient continues treatment until the investigator assesses the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, or other discontinuation criteria specified in the protocol (whichever occurs first). Follow-up treatment for patients who withdraw from treatment due to safety or ineffectiveness is determined by the investigator according to clinical practice. Safety assessment during treatment, including vital signs, physical examination, laboratory examination, etc.; Check your blood routine at least once a week. A 4-week safety visit was performed after the final treatment.

Вмешательства

• Препарат herombopag olamine tablets
  The patient received herombopag 5mg/d at the beginning of the day, was orally taken on an empty stomach in the morning, and could eat 2 hours after taking the drug, once a day for 24 weeks. Investigators will adjust the dosage of herombopag once a week according to the platelet count, with a maximum dosage of 7.5 mg per day. Efficacy and safety were evaluated once a week.

Первичные конечные точки

• Proportion of patients with platelet count ≥30×109/L [Срок оценки: 8 weeks]

Вторичные конечные точки (7)

• Proportion of patients with platelet count ≥50×109/L [Срок оценки: 8 weeks]
• Proportion of patients with platelet count ≥100×109/L [Срок оценки: 8 weeks]
• Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L [Срок оценки: 24 weeks]
• Sustained response at 24 weeks of treatment [Срок оценки: 24 weeks]
• The change in bleeding score before treatment and 8 weeks after treatment assessed using the world health organization (WHO) bleeding scale [Срок оценки: 8 weeks]
• Emergency treatment [Срок оценки: 8 weeks]
• incidence of treatment-emergent Adverse Events and TRAE [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Patients voluntarily participated in the study and signed informed consent;
• Age ≥60 years old, gender unlimited;
• ECOG PS ≤2;
• Expected survival ≥6 months;
• A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistent ITP;
• PLT < 30×109/L for at least two consecutive times with an interval of at least 1 day before medication
• Patients with laboratory test results meet the following criteria: a. alanine aminotransferase (ALT) 3.0 x or less normal limit (ULN), aspartate aminotransferase (AST) 3.0 x ULN or less; b. Serum total bilirubin ≤1.5×ULN; c. Serum creatinine ≤1.5×ULN;
• The researchers determined that patients could be treated with hexapopal.

Критерии исключения

• Patients who did not respond to previous treatment with herombopag;
• A history of allergy to thrombopoietin receptor agonist (TPO-RA) drugs;
• Combined with other important organ dysfunction, such as liver and kidney failure, cardiac insufficiency, etc.
• Secondary thrombocytopenia, such as rheumatic immune disease, chronic liver disease, hyperlienism, malignant hematologic disease, bone marrow hematopoietic exhaustion disease (such as AA, MDS), hereditary thrombocytopenia, CVID, drug-induced thrombocytopenia, etc.;
• Receive TPO-RA medication within 2 weeks prior to treatment;
• Non-steroidal anti-inflammatory drugs (aspirin, salicylate, etc.) and anticoagulants (warfarin, clopidogrel, etc.) should be taken during treatment, which have an impact on platelet function.
• There are severe active bleeding symptoms, such as gastrointestinal bleeding, intracranial bleeding, etc.
• Severe thrombotic disease, such as transient ischemic attack, myocardial infarction, pulmonary embolism, deep vein thrombosis, and disseminated intravascular coagulation (DIC), occurred within 6 months prior to the screening period;
• Have a New York Heart Society (NYHA) Class 3 or 4 congestive heart failure, or have a history of NYHA Class 3/4 congestive heart failure with a left ejection fraction (LVEF) of < 45% within 4 weeks prior to treatment;
• Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody; Hepatitis virus positive, such as HBV, HCV, etc.
• A history of cirrhosis;
• Bone marrow reticulum fiber staining (MF) ≥2 grade;
• Have an active infection that is difficult to control;
• Have a history of or accompanied by malignant tumors;
• Pregnant or lactating women;
• Any other conditions that the investigator determines are not suitable for participation in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese academy of medical science and blood disease hospital — Тяньцзинь

Идентификаторы

NCT: NCT06838949 · IIT2023054

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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