Phase III Expansion Trial for Determining the Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection in Adolescent and Adult Patients With Hemophilia A
NCT ID: NCT04845399
Last Updated: 2023-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2021-04-16
2021-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Participants will receive prophylaxis treatment with Recombinant Human Coagulation Factor VIII-Fc fusion for 6 months.
Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Participants received prophylaxis treatment at 50 IU/ kg every three days.30-50 IU/kg is recommended to administration while bleeding occurs during the experiment.
Interventions
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Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Participants received prophylaxis treatment at 50 IU/ kg every three days.30-50 IU/kg is recommended to administration while bleeding occurs during the experiment.
Eligibility Criteria
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Inclusion Criteria
* The patient and/or guardian or his or her legal representative must be able to read, understand, and provide signed informed consent, And voluntarily signed the Informed Consent Form.
* The compliance of patients appeared quite well.
* Patient who is considered by the investigators suitable for ongoing to accept previously treated.
Exclusion Criteria
* Subjects who did not participate in the Phase III clinical trial of RH-107-001.
12 Years
MALE
No
Sponsors
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Jiangsu Gensciences lnc.
INDUSTRY
Zhengzhou Gensciences Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Renchi Yang
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Capital Medical University affiliated Beijing Children's Hospital
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Henan provincial People's Hospital
Zhengzhou, He'nan, China
Henan Cancer Hospital
Zhengzhou, He'nan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Jinan central hospital
Ji'nan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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CTR20210593
Identifier Type: -
Identifier Source: org_study_id
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