Status:
RECRUITING
Clinical Study on Efficacy and Safety of Hetrombopag in the Preoperative Patients of Thrombocytopenia
Lead Sponsor:
The Third People's Hospital of Chengdu
Collaborating Sponsors:
Affiliated Hospital of North Sichuan Medical College
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- Age ≥18 years old; diagnosis of immune thrombocytopenia.
- Platelets ≤75×10\^9/L before scheduled elective surgery.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06562738
Start Date
June 1 2024
End Date
March 31 2025
Last Update
August 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chengdu Third People's Hospital
Chengdu, Sichuan, China, 610000