Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Thrombocytopenia

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Blood Platelet Disorders

Cytopenia

All eligible patients were given hetrombopag orally at an initial dose of 5 mg once daily after overnight fasting (\>8 hours of fasting) and at least 2 hours before a meal . The dose of hetrombopag could be modified on the basis of the platelet count of patients after 2 weeks of administration.

Hetrombopag

Jia Wei, PhD

The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in lower-risk MDS patients with thrombocytopenia.

The is a phase 2, single-arm, open-label clinical study assessing the efficacy and safety of hetrombopag to increase platelet count in patients with very low, low, or intermediate risk myelodysplastic syndromes(MDS) according to the revised International Prognostic Scoring System (IPSS-R) with thrombocytopenia. The primary endpoint was proportion of patients achieving platelet response at week 24.

Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective，Open-label, Single-arm Study.

proportion of patients achieving platelet responses at week 24

Patients will be assessed for response according to the IWG criteria.

Improvement in platelet counts by 24 weeks of therapy

The severity of bleeding symptoms was graded according to the World Health Organization (WHO) bleeding scale (grade 0: no bleeding; grade 1: petechiae; grade 2: mild blood loss; grade 3, gross blood loss; grade 4: debilitating blood loss).

Adverse events were recorded and graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

Tongji Hospital

associate chief physician

Stage 1： Hetrombopag lower dose； Hetrombopag higher dose

Stage 2:

Hetrombopag X mg (dose to be determined based on Stage 1 results)

Matching placebo

The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia \[platelet count \<100×109/L\], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.

A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Stage Phase Ⅲ Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets in Treatment of Chemotherapy-Induced Thrombocytopenia

Cochran-Mantel-Haenszel (CMH) test will be used to make a comparison between each hetrombopag group and the placebo group.

Will be analyzed by a log-rank test stratified by the randomization stratification factors.

The Kaplan-Meier (KM) method will be used to describe the time-to-event data.

Will be analyzed with the log rank test and KM plots

An Analysis of Covariance (ANCOVA) will be used.

Will be analyzed with the log rank test and KM plots.

Arithmetic summary statistics will be provided.

Jiangsu HengRui Medicine Co., Ltd.

Neoplasm Metastasis

All the 48 patients will be given hetrombopag 5mg/day within 24 hours after chemotherapy

All the recruited 48 patients will take hetrombopag 5mg/day within 24 hours after chemotherapy

miaofang Wu

Chemotherapy is an important treatment strategy for gynecological malignancies, such as ovarian cancer, advanced endometrial cancer, cervical cancer. Chemotherapy-induced thrombocytopenia (CIT) is one of the most common chemotherapy-related hematologic toxicities and can increase the risk of bleeding, prolong hospital stays, increase healthcare costs, and, in severe cases, death. It can lead to a reduction in the intensity of chemotherapy doses, delay the next cycle of chemotherapy, or even termination of treatment, thereby affecting the antitumor effect and adversely affecting the long-term survival of these patients. Literature and our data show that when patients develop grade II or worse CIT, the incidence of grade II and above CIT after the next cycle of chemotherapy is 85-92%. Hetrombopag is one of the thrombopoietin receptor agonist (TPO-RA) that has been studied to explore its role in the treatment and prevention of CIT in multiple solid tumors. In order to find out the secondary prevention efficacy of CIT, it is planned to carry out this single-arm prospective study by recruiting 48 patients with gynecological malignancies with grade II CIT or above after chemotherapy, whose platelets has returned to normal after the routine clinical intervention, and then plan to have the next cycle of chemotherapy. The intervention strategy is taking hetrombopag 5mg/day within 24 hours after chemotherapy, then observe the incidence rate of grade II CIT. The endpoint of this study is to assess the effectiveness and safety of hetrombopag for preventing CIT in patients with gynaecological malignancies.

The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies

The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies（the SPRIT TRIAL）

incidence of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)

the percentage of dose reduction due to thrombocytopenia

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

The first chemotherapy cycle (single center, open label, randomized controlled):

When platelets were \<50\*109/L, oral hetrombopag 7.5 mg/day was started. When the platelet count is \>100\*109/L, the administration is suspended.

2nd chemotherapy cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after chemotherapy for 14 days.

The first chemotherapy cycle (single center, open label, randomized controlled):

Start using rh-TPO 15000 units/day (subcutaneous injection) when platelets are less than 50\*109/L. When the platelet count is more than 100\*109/L, the administration is suspended.

2nd chemotherapy cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after chemotherapy for 14 days.

rh-TPO

min yan

Min Yan, Professor

Min Yan

This study now plans to explore the efficacy and safety of hetrombopag in chemotherapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

Chemotherapy-induced thrombocytopenia increases the risk of hemorrhagic complications, the need for platelet transfusions, and limits the dose of cytotoxic drugs in the treatment of certain malignancies. Thrombopoietin receptor agonist (TPO-RA) has a therapeutic effect on chemotherapy-induced thrombocytopenia (CIT). As an innovative TPO-RA drug, hetrombopag has a more optimized molecular structure and reduced liver and kidney toxicity. A registrational Phase III clinical study in CIT patients is ongoing. This study now plans to explore the efficacy and safety of hetrombopag in chemotherapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombopag in chemotherapy-induced platelets.

A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer

A Single-center, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer

Definition of response: 1. No chemotherapy regimen adjustment due to thrombocytopenia (such as chemotherapy delay ≥ 5 days, and/or chemotherapy dose reduction ≥ 20%, chemotherapy discontinuation, etc.; 2. No platelet-raising rescue therapy; 3. No Grade 4 myelosuppression; 4. Grade 3 myelosuppression for a duration of ≤ 1 week)

The lowest platelet value after chemotherapy;

The incidence of platelets \<50×109/L and \<25×109/L;

The duration of platelets \<50×109/L and \<25×109/L;

The time for platelets to recover to more than 100×109/L;

latelet recovery to the highest value after chemotherapy;

Henan Cancer Hospital

patients receive oral hetrombopag at an initial dose of 7.5 mg QD

The administration of hetrombopag as a monotherapy and at an initial dose of 7.5 mg QD.The dose adjusted based on platelet count.

Hetrombopag Olamine

Xiaonan Sun

Weiwen Zhou

Thrombocytopenia represents one of the main toxicities of concurrent chemoradiotherapy, which may necessitate chemotherapy dose reductions, dose delays, or discontinuation, and even compromise survival. Hetrombopag, a thrombopoietin receptor agonist, has shown efficacy and safety in patients with chemotherapy-induced thrombocytopenia. However, the efficacy of hetrombopag in patients who received concurrent chemoradiotherapy is not clear yet. This study aimed to evaluate the efficacy and safety of hetrombopag in this patient population.

Antitumor related therapy is one of the common causes of thrombocytopenia. Chemotherapy regimens based on drugs such as gemcitabine, platinum, anthracycline, and paclitaxel are high-risk options for thrombocytopenia. The degree of thrombocytopenia caused by external radiation therapy mainly depends on the irradiation dose, irradiation site, irradiation field size, and irradiation duration. The synchronous radiotherapy and chemotherapy regimen for head and neck tumors, esophageal cancer, rectal cancer, and other cancers often involves platinum drugs, and the irradiation site often involves flat and irregular bones. Therefore, the incidence of thrombocytopenia in patients during the treatment process is higher than that of chemotherapy or radiotherapy alone. In a phase III clinical study on the combination of carboplatin and paclitaxel in the treatment of esophageal cancer, the incidence of thrombocytopenia was as high as 54%. Once thrombocytopenia occurs, it may lead to a decrease in chemotherapy drug dosage, delay, and cessation of radiotherapy and chemotherapy, and may require platelet infusion. In follow-up studies of various cancer patients, it has been found that reducing the dosage of chemotherapy drugs or delaying the chemotherapy cycle will reduce treatment efficacy and lead to poor prognosis, including shortened disease-free survival (DFS) and overall survival (OS) time.

TPO-RA drugs are currently approved for indications in the fields of chronic primary immune thrombocytopenia (ITP), severe aplastic anemia (SAA), and chronic liver disease (CLD). There are also relevant data reports in the CIT field. A phase II clinical study using romiplostim for the treatment of CIT enrolled a total of 60 patients. After treatment with romiplostim, 85% of patients returned to normal platelet count within 3 weeks and resumed chemotherapy. In the subsequent prescribed chemotherapy cycle, only 6.8% of patients experienced a relapse due to another round of chemotherapy. The occurrence of CIT leads to a decrease or delay in chemotherapy dose; In another randomized placebo-controlled phase II study using eltrombopag for the prevention of solid tumor CIT, patients received gemcitabine monotherapy or gemcitabine combined with cisplatin/carboplatin regimen chemotherapy, and treated with eltrombopag or placebo 100mg before and 5 days after chemotherapy. In the 1-6 chemotherapy cycles, the average platelet count on the day before chemotherapy in the eltrombopag group was numerically higher than that in the placebo group, but did not reach statistically significant differences. The incidence of grade 3/4 thrombocytopenia in the eltrombopag group was lower than that in the placebo group. Among patients in the combination chemotherapy group, the average time required for eltrombopag group to recover from the lowest platelet count to normal was 8 days. The placebo group, on the other hand, requires 15 days, and the incidence of delayed/reduced chemotherapy dose or dose loss due to thrombocytopenia is lower in patients in the eltrombopag group, Therefore, in gemcitabine based chemotherapy, treatment with eltrombopag can shorten the time for platelet minimum recovery and reduce the delayed/reduced chemotherapy dose caused by thrombocytopenia. However, there is still a lack of stronger evidence-based medicine for the application of TPO-RA drugs in CIT, and there is no relevant data in the field of concurrent chemoradiotherapy induced thrombocytopenia.

Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy

A Single-arm, Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors

The response rate is defined as the proportion of patients who receive treatment with hetrombopag until PLT≥100×10\^9/L

Use Kaplan Meier method to estimate median platelet recovery time.

The number of events in which radiotherapy and chemotherapy were suspended due to thrombocytopenia, as determined by researchers

Researchers determine the number of platelet transfusion events caused by thrombocytopenia

Record the name and frequency of serious adverse events

Sir Run Run Shaw Hospital

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.

The study in a 1:1 randomization ratio (36 subjects to control group). The control group did not receive other platelet raising therapy except platelet transfusion.

The subjects will initiate treatment with 7.5 mg hetrombopag once a day, starting orally 24 hours after the end of chemotherapy. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts once every two weeks, and maximum dose should not exceed 15 mg daily. Subjects whose platelet count \<25×109/L for 2 weeks, the hetrombopag dose will be increased by 2.5mg. If subjects whose platelet count ≥100×109/L or who had received hetrombopag for 28 days, hetrombopag can be stopped. Hetrombopag Olamine is sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Emergency treatment: When the platelet count was less than 20×109/L, platelet transfusion was given according to the evaluation of the investigator.

Yi Fang, MD.,Ph.D

Xiaofeng Han, MD.,Ph.D

Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia

This study is a prospective, single center, randomized, controlled and open clinical trial initiated by the researchers to evaluate the efficacy and safety of Hetrombopag in the treatment of thrombocytopenia caused by chemotherapy in acute myeloid leukemia. The study focuses on acute myeloid leukemia patients aged 18-70 who have completed induction chemotherapy and achieved complete remission, and have received ≤ 1 course of intensive therapy for consolidation. Patients were randomly divided into the treatment group and the control group through the random number table by 1:1. The treatment group received Hetrombopag and platelet transfusion, and the control group did not receive other platelet raising therapy except platelet transfusion. The study used the proportion of subjects with effective treatment during the randomized treatment period as the main efficacy indicator. 72 patients are planned to be enrolled, with treatment group and control group=1:1.

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

A Randomized, Controlled Study on the Efficacy and Safety of Hetrombopag in the Treatment of Chemotherapy-induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

RenJi Hospital

Placebo

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag in Subjects With Chemotherapy-induced Thrombocytopenia Receiving Chemotherapy for the Treatment of Solid Tumors.

Digestive System Diseases

Liver Diseases

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

durg：Hetrombopag 5mg，once daily，oral

The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day

The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day

Lu Wang, Professor

Ti Zhang, Professor

Lu Wang, M.D.

This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.

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.

Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center

Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.

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).

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

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.

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.

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.

Fudan University

Chief physician

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Niraparib

All the enrolled 34 patients will be given hetrombopag 5mg per day for 8 weeks when they start to take Niraparib as maintenance therapy

miaofang Wu, Doctor

Jing Li, Doctor

Niraparib brings a better prognosis to those with advanced ovarian cancer and has been approved by the Food and Drug Administration（FDA ）and National Medical Products Administration（NMPA）as one of the maintenance therapies for the advanced ovarian cancer patients. Thrombocytopenia is one of the adverse effects of Niraparib, with a 61% overall incidence and 34% of the grade 3\~4 incidence. Thrombocytopenia may cause suspension or dose reduction of Niraparib which will affect the therapeutic effect of the drug.

At present, the drugs recommended by the guidelines for the treatment of thrombocytopenia are recombinant thrombopoietin (rhTPO), recombinant interleukin 11 (rhIL-11), TPO receptor agonist (TPO-RA). Hetrombopag is one of the TPO-RA, which is recommended by the Chinese expert consensus to cure the thrombocytopenia caused by poly adenosinediphosphate ribose polymerase（PARP） inhibitors, including Niraparib. However, is it effective when it is used as the primary prevention during the maintenance therapy of Niraparib? This single-arm study aims to explore the efficacy and safety of hetrombopag for the prevention of thrombocytopenia caused by Niraparib maintenance therapy in advanced ovarian cancer patients. 34 patients will be recruited and they will take hetrombopag 5mg per day for 8 weeks when they initiate the maintenance therapy with Niraparib. The primary endpoint of this study is the rate of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0（CTCAE5.0）.

The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients

incidence of Niraparib suspension due to thrombocytopenia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hetrombopag for Lower-risk MDS With Thrombocytopenia: a Prospective，Open-label, Single-arm Study.	NCT05392647	Myelodysplastic...	Hetrombopag	18 Years -	Tongji Hospital
A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia	NCT05261646	Chemotherapy-In...	Hetrombopag Matching placeb...	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies	NCT06099925	Chemotherapy-in...	Hetrombopag	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy in Advanced Breast Cancer	NCT05394285	Breast Cancer	Hetrombopag rh-TPO	18 Years - 75 Years	Henan Cancer Hospital
Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy	NCT06433830	Thrombocytopeni... Radiotherapy Si...	Hetrombopag Ola...	18 Years -	Sir Run Run Shaw Hospital
The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies	NCT06099925	Chemotherapy-in...	Hetrombopag	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia	NCT05944211	Chemotherapy-In...	Hetrombopag Ola...	18 Years - 70 Years	RenJi Hospital
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.	NCT03976882	Chemotherapy-In...	Hetrombopag Placebo	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy	NCT05442632	Hepatopathy	Hetrombopag Placebo	18 Years -	Fudan University
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients	NCT06036966	Thrombocytopeni...	Hetrombopag	18 Years - 75 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for hetrombopag

Every month we try and update this database with for hetrombopag cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hetrombopag

Every month we try and update this database with for hetrombopag cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hetrombopag cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.