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A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Summary
This study is a single arm, open, multicenter clinical trial in which the previous treated severe hemophilia A patients receive recombinant human coagulation factor VIII for injection to evaluate the efficacy and safety of on-demand treatment in the event of new bleeding events. If evaluable surgical cases occur, the overall efficacy and safety of recombinant human coagulation factor VIII for injection as a replacement therapy for severe hemophilia A PTPs during the perioperative period will be evaluated.
Official title: A Phase III Clinical Study Evaluating the Efficacy and Safety of On-demand Treatment and Perioperative Replacement Therapy With Recombinant Human Coagulation Factor VIII for Injection in Treated Severe Hemophilia A
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-11-12
Completion Date
2026-07
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
Recombinant human activated coagulation factor VIII for injection
Recombinant human coagulation factor VIII for injection is a recombinant DNA product with functional characteristics comparable to endogenous factor VIII.
Locations (12)
Fuyang Hospital Affiliated to Anhui Medical University
Fuyang, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Henan Tumor Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Drug Tower Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China