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

Phase 4

Recruiting

• Conditions: Thrombocytopenia
• Interventions: Drug: Hetrombopag

• Registration Number: NCT06562738
• Lead Sponsor: The Third People's Hospital of Chengdu

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-17
• Last Update Submitted: 2024-08-17
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-01-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Hetrombopag arm	Hetrombopag	Takes Hetrombopag 7.5 mg/day at bedtime for at most 14 days.

Primary Outcome Measures

Name	Time	Method
Platelet elevation	up to 14 days	Proportion of patients achieving perioperative platelet count goals (≥80×10\^9/ L for major surgery and ≥50×10\^9/ L for minor surgery) without emergency treatment

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	up to 14 days	The median time to reach the platelet count target;

Trial Locations

Locations (1)

Chengdu Third People's Hospital; 🇨🇳 Chengdu, Sichuan, China