29 completed, 1 terminated, 1 withdrawn. 31 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 31 | Completed 29, Terminated 1, Withdrawn 1 |
Follow Congenital Bleeding Disorder: new trials by email Literature Review of Congenital Bleeding Disorder trials Research Report on Congenital Bleeding Disorder
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B N9-GP, ALPROLIX® - Congenital Bleeding Disorder, Haemophilia B | Phase 1 | Completed | Novo Nordisk A/S | 15 | 2017-03-07 | 2023-05-26 |
| Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 50 | 2017-01-30 | 2020-02-05 |
| Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 35 | 2016-10-10 | 2019-01-30 |
| 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 turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 21 | 2016-10-04 | 2017-12-15 |
| Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Concizumab, placebo - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 24 | 2015-09-10 | 2017-07-21 |
| Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects activated recombinant human factor VII, eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Withdrawn | Novo Nordisk A/S | 2014-03-01 | 2014-03-26 | |
| A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors eptacog alfa (activated) - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 6 | 2013-09-01 | 2014-11-14 |
| Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 15 | 2012-12-01 | 2017-02-10 |
| A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects NNC172-2021 - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Terminated | Novo Nordisk A/S | 4 | 2012-06-26 | 2019-05-15 |
| Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects NNC172-2021, placebo - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 8 | 2012-03-12 | 2017-02-27 |
| A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 4 | 2011-06-01 | 2017-02-10 |
| Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients NNC 0128-0000-2011 - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 15 | 2011-01-01 | 2016-05-13 |
| Investigating Safety and Pharmacokinetics of NNC 0128-0000-2011 Compared to NNC 0128-0000-2021 in Healthy Male Subjects NNC 0128-0000-2011, NNC 0128-0000-2021 - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 12 | 2011-01-01 | 2014-08-20 |
| A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 6 | 2010-11-01 | 2017-02-10 |
| Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B NNC 0172-0000-2021, placebo - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 52 | 2010-10-25 | 2019-05-15 |
| Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 27 | 2010-09-01 | 2017-02-10 |
| Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects catridecacog, recombinant factor XIII - Congenital Bleeding Disorder, Congenital FXIII Deficiency | Phase 1 | Completed | Novo Nordisk A/S | 51 | 2010-03-01 | 2016-09-21 |
| Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 1 | Completed | Novo Nordisk A/S | 18 | 2009-08-01 | 2017-01-20 |
| A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers activated recombinant human factor VII, long acting, placebo - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 38 | 2009-07-01 | 2016-05-13 |
| Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B activated recombinant human factor VII, long acting - Congenital Bleeding Disorder, Haemophilia A | Phase 1 | Completed | Novo Nordisk A/S | 8 | 2009-06-01 | 2016-05-13 |
Showing 20 of 31. Sign in to see all of them.
Hemophilia A (20) · Hemophilia B (12) · Thrombasthenia (1)
Blood Coagulation Disorders (23) · Blood Coagulation Disorders, Inherited (23) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (23) · Genetic Diseases, Inborn (23) · Hematologic Diseases (23) · Hemic and Lymphatic Diseases (23) · Hemorrhagic Disorders (23) · Coagulation Protein Disorders (22) · Genetic Diseases, X-Linked (12) · Blood Platelet Disorders (1)
recombinant factor VIII N8 (5) · Factor VII (3) · Factor VIII (2) · concizumab (1) · factor IX Fc fusion protein (1) · nonacog beta pegol (1) · recombinant FVIII, sugar formulated (1) · recombinant factor XIII-A2 (1) · vatreptacog alfa (1)
Novo Nordisk A/S (31)
Germany (14) · United Kingdom (14) · Spain (12) · United States (10) · France (9) · Japan (6) · Austria (5) · Denmark (4) · Italy (4) · Malaysia (4) · Switzerland (4) · Israel (3) · Netherlands (2) · Serbia (2) · Sweden (2)
PMID 25495795, PMID 15230949, PMID 15870545, PMID 16270634, PMID 16556896, PMID 16734808, PMID 17880439, PMID 21443634, PMID 23398640, PMID 25641556, PMID 31011711, PMID 31618804
2009 (4), 2005 (2), 2015 (2), 2016 (2), 2008 (1), 2014 (1)