Post Marketing Surveillance Study for ADYNOVATE in South Korea

Study Identifier:
261603
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Takeda
Collaborator:
Takeda Pharma Korea Co. Ltd.
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Biological: ADYNOVATE
Date
Feb 2019 - Jan 2024
Patient Requirements
Sex: Female & Male
Age: N/A - N/A 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
Kyungpook National University Chilgok Hospital
Daegu, Republic of Korea, 41404
Status
Recruiting
Location
Kyungpook National University Hospital
Daegu, Republic of Korea, 41944
Status
Recruiting
Location
Daegu Catholic University Medical Center
Daegu, Republic of Korea, 42472
Status
Recruiting
Location
Severance Hospital Yonsei University Health System
Seoul, Republic of Korea, 03722
Status
Recruiting
Location
Kyung Hee University Hospital at Gangdong
Seoul, Republic of Korea, 05278
Status
Recruiting
Location
Kim Hugh Chul Internal Medicine
Seoul, Republic of Korea, 05538
Status
Recruiting