PEGylated Recombinant Factor VIII

BIOLOGICAL6 trials

Sponsors

Baxalta now part of Shire, Takeda

Conditions

Hemophilia A

Phase 1

BAX 855 Dose-Escalation Safety Study

CompletedNCT01599819

Baxalta now part of ShireHemophilia A

Start: 2011-09-30End: 2012-07-27Updated: 2021-05-05

Phase 2

Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

CompletedNCT01736475

Baxalta now part of ShireHemophilia A

Start: 2013-01-31End: 2014-07-17Updated: 2021-05-20

Phase 3

BAX 855 Pediatric Study

CompletedNCT02210091

Baxalta now part of ShireHemophilia A

Start: 2014-10-31End: 2015-10-23Updated: 2021-05-24

BAX 855 PK-guided Dosing

CompletedNCT02585960

Baxalta now part of ShireHemophilia A

Start: 2015-11-23End: 2018-08-05Updated: 2021-05-25

A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A

CompletedNCT02615691

Baxalta now part of ShireHemophilia A

Start: 2015-11-12End: 2024-10-29Updated: 2025-07-28

Unknown Phase

A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.

CompletedNCT04941898

TakedaHemophilia A

Start: 2021-06-30End: 2024-03-15Updated: 2024-11-15

Related Papers

Immunogenicity, safety, and efficacy of rurioctocog alfa pegol in previously untreated patients with severe hemophilia A: interim results from a phase 3, prospective, multicenter, open-label study

Expert Review of Hematology2023-08-308 citations

Targeting an elevated FVIII level using personalized rurioctocog alfa pegol prophylaxis in specific patient populations with hemophilia A: <i>post hoc</i> subanalysis of the randomized, phase 3 PROPEL study

Therapeutic Advances in Hematology2023-01-01

Clinical studies of extended-half-life recombinant FVIII products for prophylaxis in adults and children: A critical review from the physician's perspective.

2022-04-0413 citations

Immunogenicity, Efficacy and Safety of Rurioctocog Alfa Pegol in Previously Untreated Patients with Severe Hemophilia a: Interim Results from an Open-Label Multicenter Clinical Trial

Blood2021-11-053 citations

Rurioctocog Alfa Pegol Use in Immune Tolerance Induction: Interim Results from an Open-Label Multicenter Clinical Trial in Previously Untreated Patients with Severe Hemophilia a

Blood2021-11-051 citations

Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study

Blood2020-11-0571 citations

Subgroup analysis of a phase 2/3 study of rurioctocog alfa pegol in patients with severe hemophilia A: efficacy and safety in previously treated Korean patients.

2019-09-254 citations

Results from a Phase 3, Randomized, Multicenter Study of Rurioctocog alfa Pegol PK-Guided Prophylaxis Targeting 2 FVIII Trough Levels in Patients with Severe Hemophilia a (Propel Study)

Hämostaseologie2019-02-016 citations

Immunogenicity of BAX 855 in Previously Treated Patients with Congenital Severe Hemophilia Α

Blood2016-12-022 citations

Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A

Blood2015-07-08250 citations