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

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

Study Overview

• Status: Recruiting
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: Hetrombopag

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 Type: Interventional
• Enrollment (Estimated): 55
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ying Li, PhD; Phone Number: +86 028 61318717; Email: 79468064@qq.com
• Study Contact Backup: Name: Zuofeng Liu, Master; Phone Number: +86 028 61318717; Email: 641206088@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Chengdu Third People's Hospital
      • Contact: Jing Tan, PhD; Phone Number: +86 028 61318717; Email: tanjing@nsmc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Hetrombopag arm; Takes Hetrombopag 7.5 mg/day at bedtime for at most 14 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet elevation	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	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	The median time to reach the platelet count target;	up to 14 days

Collaborators and Investigators

• Sponsor: The Third People's Hospital of Chengdu
• Collaborators: Affiliated Hospital of North Sichuan Medical College
• Investigators: Principal Investigator: JING TAN, MD, 成都市第三人民医院

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 17, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Preoperative; Thrombocytopenia; Hetrombopag
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Cytopenia; Thrombocytopenia
• Other Study ID Numbers: ThirdHospitalChengdu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No