A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ,Fc Fusion Protein for Injection

Study Identifier:
CTR20220279
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Jiangsu Gensciences lnc.
Collaborator:
N/A
Study Contact Information:
N/A
Recruitment Complete

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: ADVATE
  • Drug: FRSW107
Date
Apr 2022 - Aug 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: N/A - 12 Years years
Requirements Information

Protocol Summary

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Trial Locations

Location
Status
Location
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing, China, 100045
Status
N/A
Location
Shenzhen Children's Hospita
Shenzhen, Guangdong, China, 518000
Status
N/A
Location
Nanfang Hospital of Southern Medical University
Guangzhou, Guangzhou, China, 510515
Status
N/A
Location
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430000
Status
N/A
Location
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Status
N/A
Location
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China, 610000
Status
N/A