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)
Guangdong Provincial People's Hospital
Lanzhou, Gansu, China
RECRUITINGThe First affiliated hospital of nanchang uiversity
Nanchang, Jiangxi, China
RECRUITINGBethune First Hospital Of Jilin University
Changchun, Jilin, China
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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Peking Union Medical College Hospital
Beijing, China
RECRUITINGHematology Hospital of Chinese Academy of Medical Sciences
Tianjin, China
RECRUITING