Hetrombopag for Thrombocytopenia in Patients Scheduled for Elective Hepatic Interventional Diagnostic and Therapeutic Procedures: A Clinical Study

A Clinical Study to Evaluate the Efficacy and Safety of Hetrombopag in the Treatment of Thrombocytopenia in Patients Undergoing Elective Hepatic Interventional Diagnostic and Therapeutic Procedures

This is a prospective, multicenter, open-label, randomized controlled clinical study. It includes three phases: screening period, treatment period and follow-up period. A total of 108 adult patients with thrombocytopenia (PLT < 50×10⁹/L) scheduled for elective hepatic interventional procedures will be enrolled.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombocytopenia; Hepatic Interventional Procedure
• Intervention / Treatment: Drug: Hetrombopag; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gao-Jun Teng; Phone Number: +86-02583272121; Email: gjteng@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged ≥ 18 years
• Child-Pugh class A or B
• Baseline platelet count (PLT) < 50 × 10⁹/L
• Scheduled for elective liver interventional procedures meeting the following criteria: performed between Day 7 and Day 15 after enrollment, including mainly transvascular interventional procedures (TACE/HAIC ± systemic anti-tumor therapy, TAE, Yttrium-90 radioembolization, TIPS, PTVE, etc.) and percutaneous non-vascular interventional procedures (RFA, MWA, cryoablation, liver biopsy, etc.)
• ECOG performance status 0 or 1
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, not be breastfeeding, and must agree to use effective contraception throughout the study period and for 7 days after the last dose of study drug
• Voluntarily participating in this study, providing signed informed consent, and having good compliance

Exclusion Criteria:

• Presence of other diseases that may cause thrombocytopenia, including but not limited to: aplastic anemia, myelodysplastic syndromes, chronic myeloproliferative neoplasms, congenital thrombocytopenia, drug-induced thrombocytopenia, immune thrombocytopenia, thrombocytopenia secondary to rheumatic immune diseases, etc.
• Previous or current arterial or venous thrombosis, including partial or complete thrombosis
• History of portal vein thrombosis and/or main portal vein tumor thrombus; and/or evidence of portal vein thrombosis on ultrasound, CT, or MRI during screening; and/or absence of hepatopetal portal venous flow on Doppler ultrasound; and/or portal venous flow velocity < 10 cm/s
• Scheduled for open abdominal surgery such as hepatectomy or liver transplantation
• Received platelet-increasing procedures within 90 days prior to randomization, including partial splenic artery embolization, splenic radiofrequency/microwave ablation, high-intensity focused ultrasound (HIFU) of the spleen, three-dimensional conformal therapy of the spleen, etc.
• Previous history of liver transplantation or splenectomy
• At screening, any of the following: significant liver function abnormality with ALT/AST >3×ULN or TBL >2×ULN; hepatic encephalopathy with Child-Pugh hepatic encephalopathy score of 3 (occasional coma), irrespective of hepatic encephalopathy treatment; medication-refractory ascites
• Bleeding score ≥ grade 2 according to the WHO bleeding scale prior to randomization, or history or evidence of diseases with bleeding risk
• Received platelet transfusion or platelet-containing blood products (excluding red blood cells) within 3 days prior to randomization
• Received any of the following medications within 14 days prior to randomization: TPO (e.g., rhTPO), other TPO-RA agents, recombinant human interleukin-11 (IL-11), etc.
• Any other condition deemed unsuitable for inclusion in the study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm (N=72); Hetrombopag 10 mg once daily for 5 consecutive days.	Drug: Hetrombopag; Hetrombopag 10 mg orally once daily for 5 consecutive days
Placebo Comparator: Control arm (N=36)	Drug: Placebo; Placebo 10 mg orally once daily for 5 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively and no rescue bleeding treatment within 7 days postoperatively.	The primary endpoint is the percentage of subjects who achieve platelet count ≥50×10⁹/L within 24 hours before operation and do not receive rescue treatment for bleeding during the first 7 days after surgery.	Perioperative, up to postoperative Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with PLT ≥50×10⁹/L at 24 hours preoperatively.	The percentage of subjects whose platelet count reaches ≥50×10⁹/L within 24 hours before surgery.	Within 24 hours before surgery
The proportion of participants with an increase in PLT ≥20×10⁹/L from baseline at 24 hours preoperatively.	The percentage of subjects with platelet count elevation of at least 20×10⁹/L compared with baseline at 24 hours before surgery.	Baseline and within 24 hours before surge
The proportion of participants without platelet transfusion during the study period.	The percentage of subjects who do not receive any platelet transfusion throughout the study.	Through study completion, an average of 35 days
Duration of platelet count maintaining PLT ≥50×10⁹/L.	The length of time that platelet count remains at or above 50×10⁹/L.	Through study completion, an average of 35 days
Change in platelet count at different visit time points.	The change from baseline in platelet count assessed at each scheduled study visit.	Baseline and at all scheduled study visits through study completion, an average of 35 days
The proportion of participants without delay, cancellation or discontinuation of systemic anti-tumor therapy due to thrombocytopenia.	The percentage of subjects whose systemic anti-tumor therapy is not delayed, cancelled or discontinued because of thrombocytopenia.	Through study completion, an average of 35 days
The proportion of participants requiring rescue treatment for bleeding.	The percentage of subjects who receive rescue therapy for bleeding events.	Through study completion, an average of 35 days
Number and dose of platelet transfusions.	The total number and administered dose of platelet transfusions received by subjects during the study.	Through study completion, an average of 35 days
Number of participants with at least one treatment-related adverse event, clinically significant laboratory abnormality or vital sign abnormality assessed by CTCAE v5.0	The count of subjects who develop at least one treatment-related adverse event, clinically significant laboratory abnormality or abnormal vital sign.	Through study completion, an average of 35 days

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-jun Teng, Zhongda hospital, Southeast university, Nanjing, China

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: October 13, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Hetrombopag; Thrombocytopenia Hepatic interventional procedure; Elective surgery Platelet count
• Additional Relevant MeSH Terms: Cytopenia; Hematologic Diseases; Blood Platelet Disorders; Hemic and Lymphatic Diseases; Thrombocytopenia; hetrombopag
• Other Study ID Numbers: 2026ZDSYLL341-Y01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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