A Clinical Study of Recombinant Human Coagulation Factor VIII for Injection in Patients With Severe Hemophilia A

Study Identifier:
TQG202-III-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Collaborator:
N/A
Study Contact Information:
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: Recombinant human activated coagulation factor VIII for injection
Date
Apr 2024 - Apr 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & 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
Anhui Provincial Hospital
Hefei, Anhui, China, 230002
Status
N/A
Location
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400010
Status
N/A
Location
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730013
Status
N/A
Location
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Status
N/A
Location
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Status
N/A
Location
Henan Tumor Hospital
Zhengzhou, Henan, China, 450003
Status
N/A