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HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Sponsor: Hutchison Medipharma Limited
Summary
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA Phase III Studies: Confirmation of Efficacy safety and of HMPL-523 in Adult Patients With wAIHA
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2022-09-30
Completion Date
2026-11
Last Updated
2026-03-10
Healthy Volunteers
No
Interventions
HMPL-523(300mg PO QD)
HMPL-523(300mg PO QD)
Placebo
Placebo(300mg PO QD)
Locations (39)
Fuyang Hospital Of Anhui Medical University
Fuyang, Anhui, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Nanfang hospital
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Guilin Medical College Affiliated Hospital
Guilin, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
Affiliated hospital of Hebei university
Baoding, Hebei, China
Affiliated hospital of chengde medical university
Chengde, Hebei, China
Harbin First Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University Of Science and Technology
Luoyang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangyang Center Hospital
Xiangyang, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
The third xiangya hospital of central south university
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Jiangsu province hospital
Nanjing, Jiangsu, China
Affiliated hospital of nantong university
Nantong, Jiangsu, China
Jiangxi Provincial people's Hospital
Nanchang, Jiangxi, China
The First affiliated hospital of nanchang uiversity
Nanchang, Jiangxi, China
Bethune First Hospital Of Jilin University
Changchun, Jilin, China
Qinghai provincial people's hospital
Xining, Qinghai Provincial, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Jinshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Heping Hospital Affiliated To Changzhi Medical College
Changzhi, Shanxi, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, China