Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hetrombopag.
- Who it may be relevant to
- Registry conditions: Thrombocytopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Platelet elevation [Time frame: up to 14 days]
Secondary outcome measures (1)
- Secondary Outcome [Time frame: up to 14 days]
Eligibility criteria
Inclusion criteria
- Age ≥18 years old; diagnosis of immune thrombocytopenia.
- Platelets ≤75×10\^9/L before scheduled elective surgery.
Exclusion criteria
- History of allergy to Thrombopoietin Receptor Agonists (TPO-RA) drugs;
- Severe bleeding symptoms, such as gastrointestinal bleeding, bleeding of important organs, and intracranial bleeding;
- Thrombotic diseases, such as pulmonary embolism, arterial thrombosis and disseminated intravascular coagulation (DIC);
- Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody;
- New York Heart Association (NYHA) Grade 3 or 4 congestive heart failure;
- History of angina pectoris, myocardial infarction or cerebral infarction within 6 months before the screening period;
- Have an active infection that is difficult to control;
- Pregnant or lactating women;
- Other conditions determined by the investigator to be unsuitable for inclusion in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chengdu Third People's Hospital — Chengdu
Identifiers
NCT: NCT06562738 · ThirdHospitalChengdu