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
Phase II Study: the proportion of patients with overall Hb response by Week 24 Phase III study: the proportion of patients who achieve a durable response by Week 24
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
HMPL-523(300mg PO QD)
Placebo(300mg PO QD)
Phase II: overall Hb response rate
Phase II: Overall Hb response rate: the proportion of patients with overall Hb response by Week 24
Time frame: 24Weeks
Phase III: Durable Hb response rate
Phase III: Durable Hb response rate: the proportion of patients who achieve a durable response by Week 24
Time frame: 24Weeks
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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
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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
...and 29 more locations