Status:
RECRUITING
Avatrombopag for Chemotherapy-induced Thrombocytopenia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Second Hospital
Conditions:
Chemotherapy-induced Thrombocytopenia
Avatrombopag
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of Avatrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
Detailed Description
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Avatrombopag in China, the investigato...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05218226
Start Date
February 10 2022
End Date
December 31 2025
Last Update
February 24 2025
Active Locations (1)
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1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020