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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Male or female, aged between 18-65 years;

• PLT\<20×10\^9/L or transfusion dependent on +D7 after haplo-HSCT;

• Agree to receive the treatment of avatrombopag after Haplo-HSCT and sign the informed consent form.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Xiangya Hospital, Central South University
NOT_YET_RECRUITING
Changsha
Xinqiao Hospital, Army Military Medical University
NOT_YET_RECRUITING
Chongqing
Guangzhou First People's Hospital, School of Medicine, South China University of Technology
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital, Harbin Medical University
NOT_YET_RECRUITING
Harbin
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
Shanxi Tumor Hospital Affiliated to Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Chinese Academy of Medical Sciences & Peking Union Medical College
NOT_YET_RECRUITING
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Tangdu Hospital, PLA Air Force Military Medical University
NOT_YET_RECRUITING
Xi’an
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Haixia Fu
fuhaixia_210@163.com
13581830157
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 142
Treatments
Experimental: avatrombopag
Avatrombopag 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed.~Adjustment indication:~When PLT\<50×10\^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10\^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10\^9/L excluding the factor of PLT transfusion, stop administration; When PLT\<50×10\^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d.~PLT transfusion Indication: When PLT\<20×10\^9/L, and/or with the symptom or risk of bleeding.
Placebo_comparator: Placebo
Placebo 20 mg/d will be taken orally from +D7 after haplo-HSCT until reaching the adjustment indication or to +D60 after haplo-HSCT. Routine treatment is allowed.~Adjustment indication:~When PLT\<50×10\^9/L or PLT transfusion dependent on the +D30 after haplo-HSCT, increase the dosage to 40 mg/d; When the dosage has been increased to 40 mg/d, and PLT≥80×10\^9/L excluding the factor of PLT transfusion, decrease the dosage to 20 mg/d; When PLT≥80×10\^9/L for 7 consecutive days excluding the factor of PLT transfusion, or PLT≥300×10\^9/L excluding the factor of PLT transfusion, stop administration; When PLT\<50×10\^9/L or become PLT transfusion dependent after stopping administration, initiate administration again at the dosage 40 mg/d.~PLT transfusion Indication: When PLT\<20×10\^9/L, and/or with the symptom or risk of bleeding.
Sponsors
Collaborators: The First Affiliated Hospital of Nanchang University, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Shanxi Bethune Hospital, First Affiliated Hospital of Xinjiang Medical University, Tang-Du Hospital, First Affiliated Hospital of Harbin Medical University, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, Xiangya Hospital of Central South University
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov