Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive SurgeryPhase 3NCT06507436

The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

A Phase 3 study testing Herombopag tablets in people with Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
What is being tested?: Herombopag tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 1 siteChina
Study dates: 31 Jul 2024to 14 Aug 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
Platelet count less than 50×10^9/L on baseline;
Elective invasive procedures or surgeries that are planned.

Who cannot join

Any history of arterial or venous thrombosis, including partial or complete thrombosis;
Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening;
Portal vein blood flow velocity rate <10 centimeters/second at Screening;
There are other diseases that may cause thrombocytopenia.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Hospital, affiliated with Fudan University
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

Conditions: Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery
Being tested: Herombopag tablets, Herombopag placebo tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Herombopag tabletsDrug
Herombopag tablets; dose 1 or dose 2, for 5 days
Herombopag placebo tabletsDrug
Herombopag placebo tablets; dose 1 or dose 2, for 5 days

Study groups in NCT06507436
Study group	Role	What they receive
Treatment group 1	Experimental	Not described Receives: Drug: Herombopag tablets; Drug: Herombopag placebo tablets
Treatment group 2	Experimental	Not described Receives: Drug: Herombopag tablets; Drug: Herombopag placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Part A: CL/F
Measured: 0 minute to 5 days
Part A: Vc/F
Measured: 0 minute to 5 days
Part A: ka
Measured: 0 minute to 5 days
Part A: Q/F
Measured: 0 minute to 5 days
Part A: AUC0-tau
Measured: 0 minute to 5 days
Part A: Cmax
Measured: 0 minute to 5 days
Part A: Kin
Measured: 0 minute to 35 days
Part A: Kout
Measured: 0 minute to 35 days
Part A: Kdeg
Measured: 0 minute to 35 days
Part A: Slope
Measured: 0 minute to 35 days
The proportion of subjects whose platelet count is ≥50×10^9/L within 24 hours before surgery and has increased by ≥20×10^9/L from baseline, and who have not received platelet transfusion or other treatments to raise platelet levels before surgery
Part B
Measured: 0 minute to 11 days

Secondary outcomes (2)

The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery
Measured: 0 minute to 11 days
The duration of time during the study when the platelet count remains ≥50×10^9/L
Measured: 0 minute to 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202414 Aug 2026

First posted18 Jul 2024
Study start31 Jul 2024
Primary completion14 Aug 2026
Study completion14 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive SurgeryStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Herombopag compared with placebo
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06507436
Sponsor's protocol ID: SHR8735-302
Status last verified: Oct 2025
First submitted: 12 Jul 2024
Last updated: 28 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided