This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Intravenous Injection
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Lanzhou University First Hospita
Lanzhou, Gansu, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Incidence of adverse events
Time frame: From day 0 to up to day 4
Proportion of successfully treated bleeding episodes
Time frame: 8 hours after first administration of study drug
Proportion of successfully treated bleeding episodes
Time frame: 12 hours,24 hours after first administration of study drug
Proportion of bleeding episodes received salvage treatment
Time frame: Within 3 months after enrollment
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North China University of Technology Affiliated Hospital
Tangshan, Hebei, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Gulou Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Xi'an Central Hospital
Xi’an, Shanxi, China
...and 2 more locations