Difference between revisions of "Inherited coagulopathy - null regimens"
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=Factor VIII deficiency (Hemophilia A), without inhibitors, all lines of therapy= | =Factor VIII deficiency (Hemophilia A), without inhibitors, all lines of therapy= | ||
| − | == | + | ==Observation {{#subobject:c1a40e|Regimen=1}}== |
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===References=== | ===References=== | ||
# '''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. [https://doi.org/10.1056/NEJMoa1803550 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30157389/ PubMed] [https://clinicaltrials.gov/study/NCT02847637 NCT02847637] | # '''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. [https://doi.org/10.1056/NEJMoa1803550 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30157389/ PubMed] [https://clinicaltrials.gov/study/NCT02847637 NCT02847637] | ||
| + | |||
| + | =Factor VIII deficiency (Hemophilia A), with inhibitors, all lines of therapy= | ||
| + | ==Observation {{#subobject:f198c0|Regimen=1}}== | ||
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
| + | ===Regimen {{#subobject:cbc686|Variant=1}}=== | ||
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Dates of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://doi.org/10.1056/NEJMoa1703068 Oldenburg et al. 2017 (HAVEN 1)] | ||
| + | |2015-11-17 to NR | ||
| + | |style="background-color:#1a9851"|Phase 3 (C) | ||
| + | |[[Inherited_coagulopathy#Emicizumab_monotherapy_2|Emicizumab]] | ||
| + | | style="background-color:#d73027" |Higher bleeding rate (primary endpoint) | ||
| + | |- | ||
| + | |} | ||
| + | ''No active treatment.'' | ||
| + | </div> | ||
| + | ===References=== | ||
| + | # '''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. [https://doi.org/10.1056/NEJMoa1703068 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28691557/ PubMed] | ||
[[Category:Inherited coagulopathy regimens]] | [[Category:Inherited coagulopathy regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Null regimens]] | [[Category:Null regimens]] | ||
Revision as of 15:52, 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
- 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 NR | Phase 3 (C) | Emicizumab | Higher bleeding rate (primary endpoint) |
No active treatment.
References
- 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