Haemophilia A Clinical Trial
Official title:
Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05082116 -
Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)
|
Phase 3 | |
| Completed |
NCT03660774 -
A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
|
||
| Active, not recruiting |
NCT04675541 -
Register of Patients With haEmophilia A tReated With Afstyla®
|
||
| Completed |
NCT01949792 -
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
|
Phase 1 | |
| Completed |
NCT01205724 -
Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
|
Phase 1 | |
| Completed |
NCT01562587 -
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
|
Phase 1 | |
| Completed |
NCT02246868 -
An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
|
Phase 3 | |
| Completed |
NCT01493778 -
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
|
Phase 3 | |
| Completed |
NCT02490787 -
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
|
Phase 1 | |
| Completed |
NCT02920398 -
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
|
Phase 1 | |
| Completed |
NCT03276130 -
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
|
||
| Completed |
NCT00984126 -
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
|
Phase 3 | |
| Completed |
NCT01228669 -
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
|
Phase 1 | |
| Enrolling by invitation |
NCT04574076 -
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
|
||
| Completed |
NCT01988532 -
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
|
N/A | |
| Completed |
NCT01436825 -
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
|
N/A | |
| Completed |
NCT01234545 -
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
|
N/A | |
| Completed |
NCT00245297 -
Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes.
|
Phase 2 | |
| Completed |
NCT02941354 -
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
|
Phase 1 | |
| Recruiting |
NCT05621746 -
An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct
|