Avatrombopag for Chemotherapy-induced Thrombocytopenia

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of Avatrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborators: Henan Cancer Hospital; The Second Affiliated Hospital of Kunming Medical University; Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University Second Hospital; Tianjin People's Hospital; Tianjin Third Central Hospital

Criteria

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.