16 completed, 1 active not recruiting, 1 withdrawn. 7 Phase 3, 3 Phase 1, 1 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 7 |
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 1 | Completed 1 |
| Phase 4 | 1 | Withdrawn 1 |
Follow BAX 855: new trials by email Literature Review of BAX 855 trials Research Report on BAX 855
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 Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A Adynovate - Hemophilia A | Phase 3 | Completed | Takeda | 37 | 2023-03-27 | 2025-05-01 |
| Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol - Hemophilia A | Phase 1 | Completed | Sanofi | 13 | 2021-08-11 | 2025-09-18 |
| A Study of TAK-660 in Surgical Procedures for People With Hemophilia A. PEGylated Recombinant Factor VIII - Hemophilia A | Completed | Takeda | 16 | 2021-06-30 | 2024-11-15 | |
| POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies Eloctate, Adynovate, Emicizumab - Hemophilia A, Factor VIII | Phase 4 | Withdrawn | University of Texas Southwestern Medical Center | 2021-04-15 | 2026-04-07 | |
| A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A ADYNOVI/ADYNOVATE - Hemophilia A | Active not recruiting | Baxalta now part of Shire | 207 | 2020-07-09 | 2026-02-18 | |
| Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII) Damoctocog-alfa-pegol (BAY94-9027, Jivi), Rurioctocog alfa pegol (Adynovi) - Hemophilia A | Phase 1 | Completed | Bayer | 18 | 2019-08-08 | 2020-12-21 |
| Post Marketing Surveillance Study for ADYNOVATE in South Korea ADYNOVATE - Hemophilia A | Completed | Takeda | 341 | 2019-02-25 | 2024-02-26 | |
| ADYNOVATE Drug Use-Results Survey ADYNOVATE - Hemophilia A | Completed | Takeda | 135 | 2017-02-01 | 2025-02-04 | |
| Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT® octocog alfa, rurioctocog alfa pegol - Hemophilia A, Hemophilia | Completed | Spanish Society of Thrombosis and Haemostasis | 50 | 2016-11-11 | 2023-06-08 | |
| BAX 855 PK-guided Dosing PEGylated Recombinant Factor VIII - Hemophilia A | Phase 3 | Completed | Baxalta now part of Shire | 135 | 2015-11-23 | 2021-05-25 |
| A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A PEGylated Recombinant Factor VIII, ITI - Hemophilia A | Phase 3 | Completed | Baxalta now part of Shire | 120 | 2015-11-12 | 2025-07-28 |
| ATHN 2: Factor Switching Study Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013, Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013 - Hemophilia | Completed | American Thrombosis and Hemostasis Network | 310 | 2015-09-01 | 2021-12-09 | |
| BAX 855 Pediatric Study Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII - Hemophilia A | Phase 3 | Completed | Baxalta now part of Shire | 75 | 2014-10-31 | 2021-05-24 |
| Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures PEGylated Recombinant factor VIII (rFVIII) - Hemophilia A | Phase 3 | Completed | Baxalta now part of Shire | 30 | 2013-12-20 | 2021-05-24 |
| BAX 855 Continuation BAX855 - Hemophilia A | Phase 3 | Completed | Baxalta now part of Shire | 218 | 2013-10-15 | 2021-05-24 |
| Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study) Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII - Hemophilia A | Phase 2 / Phase 3 | Completed | Baxalta now part of Shire | 159 | 2013-01-31 | 2021-05-20 |
| BAX 855 Dose-Escalation Safety Study Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII - Hemophilia A | Phase 1 | Completed | Baxalta now part of Shire | 19 | 2011-09-30 | 2021-05-05 |
| ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD) ADVATE, ADYNOVI - Hemophilia A | Completed | Baxalta now part of Shire | 951 | 2011-06-28 | 2024-06-17 |
Hemophilia A (18) · Hemarthrosis (1) · Hemorrhage (1) · Thrombosis (1)
Baxalta now part of Shire (9) · Takeda (4) · American Thrombosis and Hemostasis Network (1) · Bayer (1) · Sanofi (1) · Spanish Society of Thrombosis and Haemostasis (1) · University of Texas Southwestern Medical Center (1)
Bulgaria (10) · Spain (9) · United States (9) · United Kingdom (8) · Germany (6) · Netherlands (6) · South Korea (6) · Taiwan (6) · Ukraine (6) · Austria (5) · Japan (5) · Malaysia (5) · Sweden (5) · Switzerland (5) · Australia (4)
Ellis J Neufeld, MD, PhD (1) · Janna Journeycake, MD (1) · Jessica Garcia, MD (1)
PMID 26157075, PMID 27328112, PMID 27891721, PMID 32974838, PMID 33150384, PMID 36655343, PMID 37465396, PMID 37538505, PMID 37646148, PMID 38371314, PMID 40680470
2014 (2), 2015 (1), 2018 (1), 2023 (1)