A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Study Identifier:
CTR20220238
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Jiangsu Gensciences lnc.
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A, Severe
Study Drug
  • Drug: FRSW117
Date
Apr 2022 - Jul 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 12 - 65 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
People'S Hospital of Zhengzhou
Zhengzhou, Henan, China, 450000
Status
Recruiting
Location
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214100
Status
Recruiting
Location
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Status
Recruiting
Location
People'S Hospital of Rizhao
Rizhao, Shandong, China, 276800
Status
Recruiting
Location
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College.
Tianjin, Tianjin, China, 300020
Status
Recruiting