Haemophilia B Clinical Trial
Official title:
A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Nonacog Beta Pegol When Used for Treatment and Prophylaxis of Bleeding Episodes in Chinese Patients With Haemophilia B
The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B. Participants will be treated with N9-GP. This is a medicine that doctors can already prescribe in other countries. The medicine will be injected into a vein (intravenous injection). At the visits to the clinic, the medicine will be injected by the study doctor. When treating themselves at home, participants inject the medicine using a needle and vial set. The study will last for about 12-16 months. The participants will have between 9 and 19 visits to the clinic and possibly also some phone calls with the study doctor. At all visits to the clinic, the participants will have blood samples taken.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03660774 -
A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
|
||
| Completed |
NCT02568202 -
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
|
N/A | |
| 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 |
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 |
NCT03655340 -
A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
|
||
| Completed |
NCT03276130 -
Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B
|
||
| Completed |
NCT01228669 -
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
|
Phase 1 | |
| Completed |
NCT01988532 -
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
|
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 | |
| Enrolling by invitation |
NCT03690336 -
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
|
||
| Completed |
NCT02241694 -
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
|
N/A | |
| Completed |
NCT01220141 -
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
|
N/A | |
| Completed |
NCT01562457 -
Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State
|
Phase 1 | |
| Completed |
NCT03055611 -
A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
|
||
| Completed |
NCT01467427 -
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
|
Phase 3 | |
| Completed |
NCT03075670 -
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
|
Phase 1 | |
| Completed |
NCT02300519 -
Thrombin Generation Numerical Models Validation in Haemophilic Case
|
N/A | |
| Withdrawn |
NCT02084810 -
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT02049099 -
A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care
|
N/A | |
| Completed |
NCT01959555 -
Project to Update the Study of Congenital Haemophilia in Spain
|
N/A |