Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Previously Treated With FIX Therapy

Study Identifier:
CSL654_3004
ClinicalTrials.gov Identifier:
EudraCT Identifier:
Sponsor:
CSL Behring
Collaborator:
N/A
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia B
Study Drug
  • Biological: Recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)
Date
Jun 2024 - Dec 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: N/A - 70 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
Beijing, Beijing, China, 100045
Status
N/A
Location
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China, 350001
Status
N/A
Location
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Status
N/A
Location
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Status
N/A
Location
North China University Of Science And Technology Affiliated Hospital
Tangshan, Hebei, China, 63000
Status
N/A
Location
Jinan Central Hospital
Jinan, Shandong, China, 250013
Status
N/A