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Herombopag for Chemotherapy-induced Thrombocytopenia

RECRUITINGPhase 2Sponsored by Institute of Hematology & Blood Diseases Hospital, China
Actively Recruiting
PhasePhase 2
SponsorInstitute of Hematology & Blood Diseases Hospital, China
Started2022-03-14
Est. completion2024-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

To evaluate the efficacy and safety of Herombopag to treat chemotherapy-induced thrombocytopenia in Solid Tumors

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Aged ≥18 years old, male or female;
* Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11;
* Stop radiotherapy or chemotherapy for more than 1 month;
* Platelet counts \<30 ×10\^9/L, and bleeding tendency;
* Estimated survival period ≥ 6 months;
* People who are willing to sign the informed consent voluntarily and follow the research program.
* Liver and kidney function\<1.5×upper limit of normal, qualified for physical examination;
* Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;

Exclusion Criteria:

* Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases;
* Patients with poor compliance;
* Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
* There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator;
* Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis;
* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;
* Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up;
* Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared;
* Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.);
* Patients with sepsis or patients with other irregular bleeding;
* Patients taking antiplatelet drugs at the same time;
* Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients;
* Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block;
* Researchers believe that patients should not participate in the test of any other condition.

Conditions3

CancerChemotherapy-induced ThrombocytopeniaHerombopag

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