SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment

Study Identifier:
SS-109-I02
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Jiangsu Gensciences lnc.
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Unmapped
  • Hemophilia A With Inhibitor(s)
  • Hemophilia B With Inhibitor(s)
  • Hemophilia
Study Drug
  • Drug: SS109
Date
Oct 2023 - Jul 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 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, China
Status
Not yet recruiting
Location
The First Affiliated Hospital of Shandong First Medical University
Jinan, China
Status
Not yet recruiting
Location
The Second Affiliated Hospital of Kunming Medical University
Kunming, China
Status
Not yet recruiting
Location
Jiangxi Provincial People's Hospital
Nanchang, China
Status
Not yet recruiting
Location
Yangping Song
Shanxi, China
Status
Not yet recruiting
Location
Hematology Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Status
Recruiting