Drugs / rAHF-PFM
rAHF-PFM
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00157105 | Feb 2001 → Aug 2004 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00157157 | Apr 2004 → Sep 2009 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00357656 | May 2006 → Oct 2015 | hemophilia A | Baxalta now part of Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2013-07-04 | Biogen | Results Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their Long-Lasting Hemophilia Factor Candidate ELOCTATE™ biogen.com ↗
ELOCTATE and Advate** showed equivalent thrombin generation potential post-infusion. |
All press releases naming this drug 15 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rAHF PFM | “To evaluate the efficacy and safety of ADVATE rAHF-PFM (Baxter Healthcare Corporation), a recombinant FVIII concentrate manufactured without human or bovine blood-derived...” PMID 19216617 ↗ Mar 2009 |
| Known as | ADVATE | “To evaluate the efficacy and safety of ADVATE rAHF-PFM (Baxter Healthcare Corporation), a recombinant FVIII concentrate manufactured without human or bovine blood-derived...” PMID 19216617 ↗ Mar 2009 |
| Known as | Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method | “Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF PFM)” NCT00357656 ↗ |
| Known as | recombinant factor VIII | “Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A.” PMID 19216617 ↗ Mar 2009 |
| Known as | Recombinant Protein-Free Factor VIII | “Recombinant Protein-Free Factor VIII (rAHF-PFM)” NCT00357656 ↗ |
| Modality | Protein / enzyme biologic | “a recombinant FVIII concentrate manufactured without human or bovine blood-derived additives” PMID 19216617 ↗ Mar 2009 |
| Route | Intravenous | “rAHF-PFM was to be administered intravenously via bolus infusion” NCT00157157 ↗ |