Emicizumab PUPs and Nuwiq ITI Study

Study Identifier:
IRB00111805
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Emory University
Collaborator:
Genentech, Inc.
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: Nuwiq (low dose protocol)
  • Drug: HEMLIBRA
  • Drug: Nuwiq (Atlanta protocol)
Date
Feb 2022 - Apr 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - 21 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
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Status
Not yet recruiting
Location
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Status
Recruiting
Location
Rush University Medical Center
Chicago, Illinois, United States, 60612
Status
Not yet recruiting
Location
Indianapolis, Indiana, United States, 46260
Status
Not yet recruiting
Location
Children's Hospital of Michigan/ Wayne State University
Detroit, Michigan, United States, 48201
Status
Not yet recruiting
Location
Weill Cornell Medicine
New York, New York, United States, 10021
Status
Not yet recruiting