Congenital Bleeding Disorder Clinical Trial
Official title:
A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency. Safety Extension Trial to F13CD-3760
This trial will be conducted in Asia, Europe and the United States of America (USA).
The aim of this clinical trial is to investigate long-term safety of rFXIII when
administered for prevention of bleeding episodes in children aged between 1 and 6 years with
congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760
(mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years
dependent on when recombinant factor XIII will be commercially available in subject's
respective country for use in children of 1-6 years of age
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00978380 -
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
|
Phase 3 | |
| 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 |
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 |
NCT00108797 -
Trial of NovoSeven® in Haemophilia - Joint Bleeds
|
Phase 4 | |
| 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 |
NCT00951405 -
Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors
|
Phase 2 | |
| Completed |
NCT01876745 -
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
|
N/A | |
| 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 |
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 | |
| 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 | |
| Completed |
NCT01779921 -
Treatment of Congenital Factor VII Deficiency
|
N/A | |
| Completed |
NCT01563471 -
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02941354 -
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
|
Phase 1 | |
| Completed |
NCT02241694 -
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
|
N/A | |
| Completed |
NCT01238367 -
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543
|
Phase 1 |