DrugBiological
Antihemophilic factor, human recombinant clinical trials
Also written ADVATE and Antihemophilic factor, recombinant, manufactured protein-free.
A product of F8 protein, human; its studies count on that page too.
- studies test it
- 26
- open now
- 2
- in phase 3
- 12
- first study started
- 2001
Keep track of what changes. Save the antihemophilic factor, human recombinant studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
26 studies that test it; most in 2009 (4)
| Year | Studies |
|---|---|
| 2001 | 2 |
| 2002 | 1 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 1 |
| 2011 | 4 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 2 |
| 2017 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 2 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 4
- Phase 2
- 4
- Phase 3
- 12
- Phase 4
- 7
- No phase
- 3
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 18 · Other 8
Baxalta now part of Shire (13) · Bayer (3) · Children's Hospital Los Angeles (1) · Oregon Health and Science University (1) · Fondazione Angelo Bianchi Bonomi (1) · Novo Nordisk A/S (1) · Chulalongkorn University (1) · Takeda (1)
Often tested with
Tested in the same studies.
Factor VIII (3) · Vonicog alfa (3) · BAX 855 (2) · Factor VIII, von Willebrand factor drug combination (1) · Optivate (1)
Studies
Open first, then newest update. How each study uses antihemophilic factor, human recombinant is read from its arms, and is right about nine times in ten.
Testing it · 26
- A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)RecruitingPhase 3TakedaNCT07129343Written as ADVATE
- Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)RecruitingPhase 4Runhui WUNCT06864975Written as Advate®
- A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)CompletedPhase 3Baxalta now part of ShireNCT02932618Written as Antihemophilic Factor (Recombinant)
- A Study of ADVATE in People With Hemophilia A in IndiaCompletedPhase 4Baxalta now part of ShireNCT04985682Written as ADVATE
- Preventing Inhibitor Recurrence IndefinitelyActive, not recruitingPhase 4Children's Hospital Los AngelesNCT04621916Written as FVIII
- Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing SurgeryCompletedPhase 2/3Baxalta now part of ShireNCT00157105Written as Antihemophilic factor, recombinant, manufactured protein-free
- Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901CompletedPhase 2/3Baxalta now part of ShireNCT00157053Written as Antihemophilic factor, recombinant, manufactured protein-free
- Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia ACompletedPhase 4Baxalta now part of ShireNCT00289536Written as Antihemophilic factor, recombinant, manufactured protein-free
- BAX 855 Pediatric StudyCompletedPhase 3Baxalta now part of ShireNCT02210091Written as Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
- Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for InjectionCompletedPhase 1Baxalta now part of ShireNCT00952822Written as Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
- Early Prophylaxis Immunologic Challenge (EPIC) StudyTerminatedPhase 3Baxalta now part of ShireNCT01376700Written as Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)
- Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)CompletedPhase 2/3Baxalta now part of ShireNCT01736475Written as Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
- Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)CompletedPhase 3Baxalta now part of ShireNCT01410227Written as Recombinant factor VIIII (rFVIII)
- Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia ACompletedPhase 4Baxalta now part of ShireNCT00243386Written as Antihemophilic factor, recombinant, manufactured protein-free
- BAX 855 Dose-Escalation Safety StudyCompletedPhase 1Baxalta now part of ShireNCT01599819Written as Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
- Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia ACompletedPhase 2/3Baxalta now part of ShireNCT00157040Written as Antihemophilic factor, recombinant, manufactured protein-free
- Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. NaiveWithdrawnNot applicableCity of Hope Medical CenterNCT01051544Written as FVIII Concentrates
- Prospective Biomarkers of Bone Metabolism in Hemophilia ACompletedPhase 3Oregon Health and Science UniversityNCT02306694Written as Advate
- Survey of Inhibitors in Plasma-Product Exposed ToddlersCompletedPhase 4Fondazione Angelo Bianchi BonomiNCT01064284Written as Recombinant FVIII
- Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A SubjectsCompletedPhase 1Novo Nordisk A/SNCT00837356Written as Advate®
See all 26 studies that test antihemophilic factor, human recombinant →
Given in every arm · 7 — antihemophilic factor, human recombinant is usual care beside what is tested
- A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)RecruitingPhase 3TakedaNCT05582993Written as ADVATE
- A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for InjectionCompletedPhase 1Jiangsu Gensciences lnc.NCT04864743Written as ADVATE
- A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for InjectionCompletedPhase 1Jiangsu Gensciences lnc.NCT05251090Written as ADVATE
- A Safety, Tolerability, and Pharmacokinetics Study of a Single Intravenous Injection of Recombinant Coagulation Factor VIII Fc - Von Willebrand Factor - XTEN Fusion Protein (rFVIIIFc-VWF-XTEN) (BIVV001) in Previously Treated Adults With Severe Hemophilia A (EXTEN-A)CompletedPhase 1/2Bioverativ, a Sanofi companyNCT03205163Written as Advate (Low Dose)
- rVWF IN PROPHYLAXISCompletedPhase 3TakedaNCT02973087Written as Antihemophilic Factor (Recombinant)
- Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia ACompletedPhase 3Bioverativ Therapeutics Inc.NCT01181128Written as Advate®
- Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia ACompletedPhase 3Bioverativ Therapeutics Inc.NCT01458106Written as FVIII (PK subgroup only)
As the comparator · 3 — what is tested is compared with antihemophilic factor, human recombinant
- A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand DiseaseRecruitingPhase 3Hoffmann-La RocheNCT06998524Written as Factor VIII (FVIII) Concentrates
- Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia ACompletedPhase 4Baxalta now part of ShireNCT00666406Written as Recombinant Factor VIII (rAHF)
- BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia ATerminatedPhase 2BayerNCT00623727Written as rFVIII-FS/WFI (BAY14-2222)
Codes
What other systems call antihemophilic factor, human recombinant · ClinicalTrials.gg INT017558
- UNII (FDA) P89DR4NY54ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANTConfirmed FDA, Wikidata
- RxNorm 1300486Confirmed FDA, Wikidata
- Wikidata Q4661156antihemophilic factor, human recombinantConfirmed FDA, Wikidata
- NCI Thesaurus C81123Antihemophilic Factor, Human RecombinantConfirmed FDA, Wikidata
- DrugBank DB00025One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| UNII (FDA) | P89DR4NY54 | ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT | Confirmed FDA, Wikidata |
| RxNorm | 1300486 | — | Confirmed FDA, Wikidata |
| Wikidata | Q4661156 | antihemophilic factor, human recombinant | Confirmed FDA, Wikidata |
| NCI Thesaurus | C81123 | Antihemophilic Factor, Human Recombinant | Confirmed FDA, Wikidata |
| DrugBank | DB00025 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.