Drugs / Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM)
last change Feb 2021 re-read 3 minutes ago

Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM)

also known as Factor VIII

Protein / enzyme biologic

Investigated by
Baxalta now part of Shire

Trials 1

2009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT00952822 Aug 2008 → Oct 2009 hemophilia A Baxalta now part of Shire Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2021-02-03 Takeda Results Data at EAHAD 2021 Highlight Value of Takeda’s Leading Hematology Portfolio in Clinical Settings and Commitment to Patient-Focused Advancements takeda.com ↗
Seven year AHEAD study data [ABS034] showed that prophylactic antihemophilic factor (recombinant), rAHF (ADVATE), achieved lower annualized bleeding rates (ABRs) and annualized joint bleeding rates (AJBRs) than on-demand treatment in all patients with severe hemophilia A.
2020-06-15 Takeda Results Takeda Provides Updates on its Hemophilia Studies at WFH 2020, Reinforcing its Commitment to Putting Patients First and Supporting Personalized Care for People with Bleeding Disorders takeda.com ↗
The update is one of the three abstracts being presented at WFH 2020 from Takeda’s Hematology portfolio and pipeline.
2018-12-01 Takeda Results Initial Data from Shire Collaboration Identifies Key Biomarkers That Affect Bleeding Patterns, Response to Treatment for Hemophilia A takeda.com ↗
The study also supports the feasibility of using limited, 2-sample PK profiling to capture accurate PK curves that can then be utilized to guide individualized, PK-guided prophylaxis.

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) ClinicalTrials.gov intervention name — accepted as the source's own label NCT00952822 ↗
Known as Factor VIII “Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)” NCT00952822 ↗
Modality Protein / enzyme biologic “Biological: Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM).” NCT00952822 ↗