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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Thrombocytopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Hetrombopag arm

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

Group Type EXPERIMENTAL

Hetrombopag

Intervention Type DRUG

Hetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10\^9/L, and take blood routine examination weekly, drug administration was resumed when PLT \< 100 ×10\^9/L. When PLT ≤30× 10\^9/L or ≥300 ×10\^9/L, take blood routine examination every 3 days.

Interventions

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Hetrombopag

Hetrombopag 7.5 mg, once a day, at bedtime for up to 14 days, drug administration was stopped when PLT≥100 ×10\^9/L, and take blood routine examination weekly, drug administration was resumed when PLT \< 100 ×10\^9/L. When PLT ≤30× 10\^9/L or ≥300 ×10\^9/L, take blood routine examination every 3 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No