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

NCT06562738 | Recruiting Phase 4

• 1 other identifier: ThirdHospitalChengdu
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Thrombocytopenia

Keywords

Hetrombopag; Thrombocytopenia; Preoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Outcome

  up to 14 days

Study Arms (1)

Experimental: Hetrombopag arm

EXPERIMENTAL

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

Drug: Hetrombopag

Interventions

Hetrombopag 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.

Experimental: Hetrombopag arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old; diagnosis of immune thrombocytopenia.
• Platelets ≤75×10\^9/L before scheduled elective surgery.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead
• Affiliated Hospital of North Sichuan Medical College: collaborator

Study Sites (1)

Chengdu Third People's Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Interventions

hetrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• JING TAN, MD

  成都市第三人民医院

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Li, PhD

CONTACT

+86 028 61318717; 79468064@qq.com

Zuofeng Liu, Master

CONTACT

+86 028 61318717; 641206088@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 20, 2024
• Study Start: June 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)