Clinical trial NCT04845399: 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
Official title: A Single-Arm, Multicenter, Open-label Phase III Expansion Trial Evaluating Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: Hemophilia A
Factor VIII-Fc Fusion Protein
Phase III Expansion Trial
Efficacy and Safety
Lead sponsor: Zhengzhou Gensciences Inc
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Gensciences lnc.
First posted: 2021-04-15
Enrollment: 101
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A.


Eligibility criteria: Inclusion Criteria:

* Patients Who have Completed trial of RH-107-001 (previously treated patients) Previously received Recombinant Human Coagulation Factor VIII-Fc prophylactic.
* 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 have not completed trial of RH-107-001or who have completed the Phase III clinical trial but not willing to continue receiving treatment.
* Subjects who did not participate in the Phase III clinical trial of RH-107-001.

Primary outcomes:
measure: Annualized Bleeding Rates (ABR).
timeFrame: For the duration of study participation, 6 months.
measure: Number of target joints.
timeFrame: For the duration of study participation, 6 months.
measure: Annualized Joint Bleeding Rate (AJBR)
timeFrame: For the duration of study participation, 6 months.
Secondary outcomes:
measure: Total Dose Required for Resolution of a Bleeding Episode.
timeFrame: For the duration of study participation, 6 months.
measure: Number of injections required to resolve a bleeding episode.
timeFrame: For the duration of study participation, 6 months.
measure: Quality of life assessment.
timeFrame: For the duration of study participation, 6 months.
measure: Score of bleeding symptoms and Vital signs.
timeFrame: For the duration of study participation, 6 months.
measure: Number of participants with inhibitor development
timeFrame: For the duration of study participation, 6 months.
measure: Number of Participants With Incidence of Antibody Formation to CHINESE HAMSTER OVARY (CHO).
timeFrame: For the duration of study participation, 6 months.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events. (SAEs) as a Measure of Safety and Tolerability.
timeFrame: For the duration of study participation, 6 months.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Capital Medical University affiliated Beijing Children's Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangzhou
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangzhou
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zhengzhou
country: China
facility: Henan provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Ji'nan
country: China
facility: Jinan central hospital
state: Shandong
city: QingDao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
name: Renchi Yang
role: PRINCIPAL_INVESTIGATOR
References: