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.
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
- Are there results?
- None posted in the registry
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
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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06507436
- Acronym / sponsor ID
- SHR8735-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Herombopag compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: Herombopag tablets, Drug: Herombopag placebo tablets |
| Treatment group 2 | Experimental | Drug: Herombopag tablets, Drug: Herombopag placebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herombopag tabletsHerombopag tablets; dose 1 or dose 2, for 5 days | Drug | Treatment group 1, Treatment group 2 |
| Herombopag placebo tabletsHerombopag placebo tablets; dose 1 or dose 2, for 5 days | Drug | Treatment group 1, Treatment group 2 |
Primary outcome
Part A: CL/F
Time frame: 0 minute to 5 days
Part A: Vc/F
Time frame: 0 minute to 5 days
Part A: ka
Time frame: 0 minute to 5 days
Part A: Q/F
Time frame: 0 minute to 5 days
Part A: AUC0-tau
Time frame: 0 minute to 5 days
Part A: Cmax
Time frame: 0 minute to 5 days
Part A: Kin
Time frame: 0 minute to 35 days
Part A: Kout
Time frame: 0 minute to 35 days
Part A: Kdeg
Time frame: 0 minute to 35 days
Part A: Slope
Time frame: 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
Time frame: 0 minute to 11 days
Part B
2 secondary outcomes
The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery
Time frame: 0 minute to 11 days
The duration of time during the study when the platelet count remains ≥50×10^9/L
Time frame: 0 minute to 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: CL/F (time frame: 0 minute to 5 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.