Difference between revisions of "Inherited coagulopathy - null regimens"

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|[https://doi.org/10.1056/NEJMoa1703068 Oldenburg et al. 2017 (HAVEN 1)]
 
|[https://doi.org/10.1056/NEJMoa1703068 Oldenburg et al. 2017 (HAVEN 1)]
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|style="background-color:#1a9851"|Phase 3 (C)
 
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[Inherited_coagulopathy#Emicizumab_monotherapy_2|Emicizumab]]
 
|[[Inherited_coagulopathy#Emicizumab_monotherapy_2|Emicizumab]]

Latest revision as of 20:36, 29 July 2024

The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main inherited coagulopathy page for regimens that include active treatment.


Factor VIII deficiency (Hemophilia A), without inhibitors, all lines of therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Mahlangu et al. 2018 (HAVEN 3) 2016-09 to not reported Phase 3 (C) Emicizumab Higher bleeding rate (primary endpoint)

No active treatment.

References

  1. HAVEN 3: Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jiménez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-822. link to original article PubMed NCT02847637

Factor VIII deficiency (Hemophilia A), with inhibitors, all lines of therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Oldenburg et al. 2017 (HAVEN 1) 2015-11-17 to not reported Phase 3 (C) Emicizumab Higher bleeding rate (primary endpoint)

No active treatment.

References

  1. HAVEN 1: Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. Epub 2017 Jul 10. link to original article PubMed