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RECRUITING
NCT06202625
PHASE2/PHASE3

Efficacy and Safety of Avatrombopag in the Treatment of Thrombocytopenia After Haplo-HSCT

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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