A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

Study Identifier:
WP44714
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Hoffmann-La Roche
Collaborator:
N/A
Study Contact Information:
Recruiting

Study Details

Medical Condition
  • Hemophilia A
Study Drug
  • Drug: NXT007
Date
Sep 2023 - Jun 2032
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 2 - 59 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
UC Davis Cancer Center
Sacramento, California, United States, 95817
Status
Recruiting
Location
Georgetown Uni Medical Center
Washington, District of Columbia, United States, 20007
Status
Recruiting
Location
Indiana Hemophilia & Thrombosis center
Indianapolis, Indiana, United States, 46260
Status
Recruiting
Location
University of Iowa Hospitals and Clnics Dept of Pediatrics
Iowa City, Iowa, United States, 52242
Status
Recruiting
Location
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Status
Recruiting
Location
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8N 3Z5
Status
Recruiting