A Study of SerpinPC in Participants with Hemophilia B (HemB) with Inhibitors

Study Identifier:
AP-0103
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
ApcinteX Ltd
Collaborator:
Centessa Pharmaceuticals plc
Study Contact Information:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia B With Inhibitor(s)
  • Hemophilia B
Study Drug
  • Drug: SerpinPC
Date
Jul 2023 - Nov 2024
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
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045-7202
Status
N/A
Location
University of South Florida
Tampa, Florida, United States, 33612
Status
N/A
Location
East Carolina University
Greenville, North Carolina, United States, 27834
Status
N/A
Location
Centre of Haematology named after prof. R. O. Yeolian/ Hemophilia center
Yerevan, Armenia, 0014
Status
N/A
Location
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Status
N/A
Location
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Status
N/A