Haemophilia B Clinical Trial
Official title:
Observatory of Patients With Haemophilia B Treated by IdElvion®
OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.
Haemophilia B is a congenital coagulation disorder caused by a deficiency or anomaly of coagulation factor IX (FIX). The severity of the haemophilia depends on the extent of the FIX deficiency with clinical manifestations differing depending on the location of the bleed. Treatment of this disease involves the administration of the deficient factor, i.e. FIX, to patients. Depending on the severity of the disease and context, a range of treatment regimens are available (long-term prophylactic treatment for the prevention of non-surgical bleeds, short-term prophylactic treatment for high-risk periods, treatment for the prevention of surgical bleeds or on-demand curative treatment). CSL Behring has developed a long-acting recombinant FIX, i.e. rIX-FP (Idelvion®), to extend the intervals between the administrations of treatment while also providing a therapeutic benefit. Data from clinical studies clearly confirm the therapeutic benefit of Idelvion® in adult and paediatric patients with haemophilia B previously receiving an on-demand treatment for bleeding episodes, for long-term prophylaxis, as well as in patients undergoing surgery. ;
| 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
|
||
| Active, not recruiting |
NCT05365217 -
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
|
Phase 3 | |
| 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 |
NCT01959555 -
Project to Update the Study of Congenital Haemophilia in Spain
|
N/A |