85 completed, 1 terminated, 1 withdrawn. 31 Phase 1, 20 Phase 3, 5 Phase 2, 4 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 31 | Completed 29, Terminated 1, Withdrawn 1 |
| Phase 3 | 20 | Completed 20 |
| Phase 2 | 5 | Completed 5 |
| Phase 4 | 4 | Completed 4 |
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 |
|---|---|---|---|---|---|---|
| Study for Turoctocog Alfa Treatment Regimen in Iraqi Haemophilia A Patients Turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 329 | 2024-11-10 | 2026-06-17 | |
| Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 10 | 2018-06-20 | 2021-11-15 | |
| A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A Turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 160 | 2018-04-30 | 2022-12-22 |
| Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 4 | Completed | Novo Nordisk A/S | 60 | 2018-03-01 | 2020-04-17 |
| A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors Concizumab, Eptacog alfa - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Phase 2 | Completed | Novo Nordisk A/S | 26 | 2017-08-10 | 2021-10-22 |
| 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 |
| Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 68 | 2016-12-12 | 2020-07-27 |
| 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 |
| A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan recombinant factor XIII - Congenital Bleeding Disorder, Congenital FXIII Deficiency | Completed | Novo Nordisk A/S | 8 | 2016-03-16 | 2025-08-29 | |
| 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 |
| Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) No treatment given - Haemostasis, Congenital Bleeding Disorder | Completed | Novo Nordisk A/S | 449 | 2015-09-01 | 2016-01-12 | |
| Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial No treatment given - Congenital Bleeding Disorder, Haemophilia A With Inhibitors | Phase 2 | Completed | Novo Nordisk A/S | 19 | 2015-04-03 | 2019-01-04 |
| To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives No treatment given - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 200 | 2014-11-01 | 2015-07-10 | |
| A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan eptacog alfa (activated) - Congenital Bleeding Disorder, Glanzmann's Disease | Completed | Novo Nordisk A/S | 4 | 2014-10-07 | 2017-07-11 | |
| To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 40 | 2014-08-04 | 2021-11-15 | |
| Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B nonacog beta pegol - Congenital Bleeding Disorder, Haemophilia B | Phase 3 | Completed | Novo Nordisk A/S | 54 | 2014-07-02 | 2025-12-23 |
| Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A turoctocog alfa pegol - Congenital Bleeding Disorder, Haemophilia A | Phase 3 | Completed | Novo Nordisk A/S | 124 | 2014-06-26 | 2025-12-23 |
| Safety and Efficacy of Turoctocog Alfa During Long-Term Treatment of Severe and Moderately Severe Haemophilia A turoctocog alfa - Congenital Bleeding Disorder, Haemophilia A | Completed | Novo Nordisk A/S | 69 | 2014-06-05 | 2020-04-27 |
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Hemophilia A (44) · Hemophilia B (27) · Thrombasthenia (4)
Blood Coagulation Disorders (56) · Blood Coagulation Disorders, Inherited (56) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (56) · Genetic Diseases, Inborn (56) · Hematologic Diseases (56) · Hemic and Lymphatic Diseases (56) · Hemorrhagic Disorders (56) · Coagulation Protein Disorders (52) · Genetic Diseases, X-Linked (27) · Blood Platelet Disorders (4)
recombinant factor VIII N8 (15) · Factor VII (14) · nonacog beta pegol (6) · recombinant factor XIII-A2 (5) · recombinant FVIIa (4) · Factor VIII (3) · vatreptacog alfa (3) · anti-inhibitor coagulant complex (2) · concizumab (2) · Factor IX (1) · factor IX Fc fusion protein (1) · recombinant FVIII, sugar formulated (1)
Novo Nordisk A/S (87)
United States (45) · United Kingdom (41) · Spain (35) · Germany (34) · Japan (33) · France (31) · Italy (29) · Malaysia (22) · Turkey (Türkiye) (21) · Israel (19) · Austria (18) · Switzerland (15) · Brazil (14) · Taiwan (14) · Canada (13)
PMID 25495795, PMID 25643920, PMID 25273984, PMID 26679394, PMID 32293786, PMID 15230949, PMID 15870545, PMID 16270634, PMID 16556896, PMID 16601828, PMID 16734808, PMID 17723130, PMID 17880439, PMID 17938794, PMID 18081834, PMID 21158750, PMID 21443634, PMID 22356641, PMID 22451421, PMID 22470921, PMID 23398640, PMID 23551918, PMID 23578227, PMID 23647704, PMID 23651313, PMID 23834599, PMID 23902228, PMID 25263390, PMID 25641556, PMID 25677761, PMID 26001792, PMID 26001793, PMID 26058730, PMID 26619194, PMID 26970716, PMID 27174727, PMID 27291066, PMID 27352908, PMID 27904904, PMID 28581691, PMID 31011711, PMID 31444162, PMID 31523745, PMID 31618804, PMID 32369845, PMID 32544297, PMID 32940955, PMID 35290453, PMID 35858373, PMID 36924249
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