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Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT
Sponsor: Peking University People's Hospital
Summary
In this study, investigators aim to evaluate the efficacy of avatrombopag in thrombocytopenic patients after haploidentical hematopoietic stem cell transplantation (haplo-HSCT) through a prospective, multi-center, double-blinded, randomized placebo-controlled clinical trial.
Official title: Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haploidentical Hematopoietic Stem Cell Transplantation: Prospective, Multi-center, Double-blinded, Randomized Placebo-controlled Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2024-05-13
Completion Date
2025-10-30
Last Updated
2024-10-01
Healthy Volunteers
No
Interventions
avatrombopag
The avatrombopag 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase avatrombopag dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within avatrombopag dosage at 40 mg/d, decrease avatrombopag dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop avatrombopag; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping avatrombopag , reuse avatrombopag at 40 mg/d.
Placebo
The placebo 20mg/d will be orally taken from +D7 after haplo-HSCT until meeting the adjustment indication or to +D60 after haplo-HSCT; When PLT\<50×10\^9/L or PLT transfusion-dependent on the +D30 after haplo-HSCT, increase placebo dosage to 40 mg/d; When PLT≥80×10\^9/L and without PLT transfusion within placebo dosage at 40 mg/d, decrease placebo dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days or PLT≥300×10\^9/L and without PLT transfusion, stop placebo; When PLT\<50×10\^9/L or PLT transfusion-dependent after stopping placebo, reuse placebo at 40 mg/d.
Locations (14)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Guangzhou First People's Hospital, School of Medicine, South China University of Technology
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shanxi Tumor Hospital Affiliated to Shanxi Medical University
Taiyuan, Shanxi, China
Tangdu Hospital, PLA Air Force Military Medical University
Xi’an, Shanxi, China
Xinqiao Hospital, Army Military Medical University
Chongqing, Sichuan, China
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China
Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China