HepatopathyPhase 2NCT05442632
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy
A Phase 2 study testing Hetrombopag in people with Hepatopathy, run by Fudan University at 1 site in China.
Trial summary
This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatopathy
- What is being tested?
- Hetrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2022to 30 Dec 2025
- Phase
- Phase 2
- 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
- 1. Male and female subjects ≥18 years of age；
- 2.Patients prepared to receive hepatectomy；
- 3.50×10^9/L≤platelet count≤80×10^9/L；
- 4.Child-PUgh score A or grade B (≤7 )；
- 5.Life expectancy ≥3 months；
- 6.Normal Bone marrow hematopoiesis and renal function;
- 7.Voluntary participation and written informed consent;
Who cannot join
- 1.Central nervous system diseases caused by liver disease;
- 2.Platelet transfusion within 7 days prior to the first dose of study drug;
- 3.History of any primary hematologic disorder;
- 4.History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system;
- 5.Pre-diagnosed Immune Thrombocytopenic Purpura (ITP);
- 6.History of Myelodysplastic Syndrome (MDS);
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- 7.Those with bleeding tendency，have evidence of hereditary bleeding or blood coagulation disorder;
- 8.Females who are pregnant (positive β-hCG test ) or breastfeeding;
- 9.Subjects who have participated in another investigational trial within 30 days prior to Visit 1;
- 10.Those with uncontrollable neurological and psychiatric diseases or mental disorders, poor compliance, unable to cooperate and describe treatment response;
- 11.Subjects with known intolerance or allergy to any of the ingredients in eltrombopag tablets;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200062
Lu Wang, M.D., +86-15800680751, w.lr@hotmail.com
About this study
Official title: Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center
This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.
Read the detailed description
The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.
- Conditions
- Hepatopathy
- Being tested
- Hetrombopag, Placebo
- Keywords
- Hepatopathy, thrombocytopenia, Hetrombopag
- Medical subject headings
- Digestive System Diseases, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day
PlaceboDrug
The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 1 | Experimental | durg：Hetrombopag 5mg，once daily，oral Receives: Drug: Hetrombopag |
| Experimental: 2 | Experimental | Ndurg： Placebo 5mg，once daily，oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period
Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.
Measured: From the start of using the investigational drug to 7 days after surgery completion
Secondary outcomes (5)
Proportion of patients with bleeding after surgery need intervention.
The World Health Organization Bleeding Scale was used to assess bleeding following surgery.. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).
Measured: up to 7 days following surgery。
Changes in preoperative Platelet count compared to baseline
Platelet count were determined from blood draws. platelet count collect on baseline and prior to 1 days of surgery. Missing platelet count assessments at any given time point was considered to be a non-response at that point and were not estimated
Measured: baseline and up to 1 days prior to surgery
Proportion of patients whose Platelet count returned to ≥80×10^9/L
Platelet count were determined from blood draws. platelet count collect on baseline and prior to 1 days of surgery. Missing platelet count assessments at any given time point was considered to be a non-response at that point and were not estimated.
Measured: baseline and up to 1 days prior to surgery
Incidence of deep venous thrombosis
Imaging examination will be conducted at d1、d3、d5、d7、d14、end of one month、 end of three month after surgery, to evaluate deep venous thrombosis if necessary.
Measured: up to 3 months following surgery.
Incidence of liver failure
Posthepatectomy liver failure is defined as: A postoperatively acquired deterioration in the ability of the liver to maintain its synthetic, excretory, and detoxifying functions, characterized by an increased international normalized ratio A postoperatively acquired deterioration in the ability of the liver to maintain its synthetic, excretory, and detoxifying functions, characterized by an increased international normalized ratio and hyperbilirubinemia on or after postoperative day 5. If international normalized ratio or serum bilirubin concentration is increased preoperatively, Post hepatectomy liver failure is defined by an increasing international normalized ratio and increasing serum bilirubin concentration on or after postoperative day 5 Other obvious causes for the observed biochemical and clinical alterations such as biliary obstruction should be ruled out. The evaluate of liver failure was conducted at d1、d3、d5、d7、d14、end of one month、 end of three month after surgery.
Measured: up to 3 months following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start25 Jul 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatopathyStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Lu Wang, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442632
- Sponsor's protocol ID
- OBU-SH-HCC-II-010
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center
- ClinicalTrials.gov ID
- NCT05442632
- Acronym / sponsor ID
- OBU-SH-HCC-II-010
- Conditions
- Hepatopathy
- Keywords
- Hepatopathy, thrombocytopenia, Hetrombopag
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Jul 2022 (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 is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.
Detailed description
The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 1 | Experimental | Drug: Hetrombopagdurg：Hetrombopag 5mg，once daily，oral |
| Experimental: 2 | Experimental | Drug: PlaceboNdurg： Placebo 5mg，once daily，oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Male and female subjects ≥18 years of age；
- 2.Patients prepared to receive hepatectomy；
- 3.50×10^9/L≤platelet count≤80×10^9/L；
- 4.Child-PUgh score A or grade B (≤7 )；
- 5.Life expectancy ≥3 months；
Key exclusion criteria (11 listed)
- 1.Central nervous system diseases caused by liver disease;
- 2.Platelet transfusion within 7 days prior to the first dose of study drug;
- 3.History of any primary hematologic disorder;
- 4.History of arterial or venous thrombosis, including thrombosis of any part of the splenic-mesenteric system;
- 5.Pre-diagnosed Immune Thrombocytopenic Purpura (ITP);
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 |
|---|---|---|
| HetrombopagThe patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day | Drug | Experimental: 1 |
| PlaceboThe patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day | Drug | Experimental: 2 |
Primary outcome
The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period
Time frame: From the start of using the investigational drug to 7 days after surgery completion
Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.
5 secondary outcomes
Proportion of patients with bleeding after surgery need intervention.
Time frame: up to 7 days following surgery。
Changes in preoperative Platelet count compared to baseline
Time frame: baseline and up to 1 days prior to surgery
Proportion of patients whose Platelet count returned to ≥80×10^9/L
Time frame: baseline and up to 1 days prior to surgery
Incidence of deep venous thrombosis
Time frame: up to 3 months following surgery.
Incidence of liver failure
Time frame: up to 3 months following surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Lu Wang, Professor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hetrombopag in people with Hepatopathy, run by Fudan University 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Mar 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Wang, Professor (18121299555, wang.lu99@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who require blood product infusion or intervention with platelet raising drugs due to bleeding during the perioperative period (time frame: From the start of using the investigational drug to 7 days after surgery completion). 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 13 Mar 2024.