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

NCT ID: NCT06507436

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-12-31

Brief Summary

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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 Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.

Detailed Description

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Conditions

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Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Herombopag compared with placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group 1

Group Type EXPERIMENTAL

Herombopag tablets

Intervention Type DRUG

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

Herombopag placebo tablets

Intervention Type DRUG

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

Treatment group 2

Group Type EXPERIMENTAL

Herombopag tablets

Intervention Type DRUG

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

Herombopag placebo tablets

Intervention Type DRUG

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

Interventions

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Herombopag tablets

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

Intervention Type DRUG

Herombopag placebo tablets

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, affiliated with Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ting Zhang

Role: CONTACT

+86 0518-82342973

Facility Contacts

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Jian Zhou, Doctor

Role: primary

+86-021-64041990

Other Identifiers

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SHR8735-302

Identifier Type: -

Identifier Source: org_study_id

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