Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia

The Third People's Hospital of Chengdu

Status and phase: Enrolling; Phase 4

Conditions: Thrombocytopenia

Treatments: Drug: Hetrombopag

Study type: Interventional

Funder types: Other

Identifiers

NCT06562738

ThirdHospitalChengdu

Details and patient eligibility

About

This is an investigator-initiated, single-arm, prospective clinical study to evaluate the efficacy and safety of heptapopal in the treatment of thrombocytopenia prior to elective surgery

Full description

It was planned to include 55 patients with immune thrombocytopenia with preoperative platelet ≤75×10^9/L. After signing the informed consent letter, the patients will enter the screening period (up to 7 days), and after passing the screening, they will receive oral hexapopal treatment, the specific medication regimen is: 7.5mg, once a day, taken orally on an empty stomach before going to bed, for a maximum of 14 days, and stop the drug when PLT≥100×10^9/L. During the oral administration of hexapopal, the administration was suspended when PLT≥200×10^9/L, and continued when the blood image was monitored weekly until PLT < 100×10^9/L. During the treatment period, blood routine was monitored every 7 days, and when PLT≤30×10^9/L or ≥300×10^9/L, blood routine was monitored every 3 days. Patients will have an end-of-treatment visit within 7 days of stopping treatment, followed by a 30-day safe follow-up period.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old; diagnosis of immune thrombocytopenia.
2. Platelets ≤75×10^9/L before scheduled elective surgery.

Exclusion criteria

1. History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
2. Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
3. Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
4. Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
5. New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
6. History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
7. Have an active infection that is difficult to control;
8. Pregnant or lactating women;
9. Other conditions determined by the investigator to be unsuitable for inclusion in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Experimental: Hetrombopag arm

Experimental group

Description:

Takes Hetrombopag 7.5 mg/day at bedtime for at most 14 days.

Treatment:

Drug: Hetrombopag