Trial Profile
A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 02 Feb 2022
Price :
$35
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At a glance
- Drugs Emicizumab (Primary) ; Eptacog alfa; Factor VIII inhibitor bypassing fraction
- Indications Haemophilia A
- Focus Registrational; Therapeutic Use
- Acronyms HAVEN 1
- Sponsors Chugai Pharmaceutical; Roche
- 14 Dec 2021 Results of post hoc pooled analysis (n=504) assessing efficacy and safety of emicizumab in persons with hemophilia A aged greater than equal to 50 years with CV risk factors or HIV and/or HCV infection from HAVEN 1 (NCT02622321), 3 (NCT02847637), 4 (NCT03020160) and STASEY (NCT03191799) studies, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
- 03 Dec 2021 Data from this study used to assess cost-effectiveness of emicizumab prophylaxis therapy and rFVIIa on-demand therapy for HA patients with inhibitors in China the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
- 01 Nov 2021 Results assessing immunogenicity of emicizumab in seven phase 3/3b clinical studies (HAVEN 1-5, HOHOEMI and STASEY) in persons with haemophilia A, published in the Haemophilia.