Difference between revisions of "Hereditary hemorrhagic telangiectasia - null regimens"
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===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| − | !style="width: | + | !style="width: 20%"|Study |
| − | !style="width: | + | !style="width: 20%"|Dates of enrollment |
| − | !style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://doi.org/10.1016/j.thromres.2014.06.012 Geisthoff et al. 2014 (TAHHT)] | ||
| + | |2002-03-01 to 2002-05-31 | ||
| + | | style="background-color:#1a9851" |Phase 3 (C) | ||
| + | |[[Hereditary_hemorrhagic_telangiectasia#Tranexamic_acid_monotherapy|Tranexamic acid]] | ||
| + | | style="background-color:#ffffbf" |Did not meet primary endpoint of hemoglobin levels<sup>1</sup> | ||
|- | |- | ||
|[https://doi.org/10.1002/lary.20065 Yaniv et al. 2009] | |[https://doi.org/10.1002/lary.20065 Yaniv et al. 2009] | ||
| + | |2005-02 to 2006-01 | ||
| style="background-color:#1a9851" |Randomized Phase 2 (C) | | style="background-color:#1a9851" |Randomized Phase 2 (C) | ||
|[[Hereditary_hemorrhagic_telangiectasia#Tamoxifen_monotherapy|Tamoxifen]] | |[[Hereditary_hemorrhagic_telangiectasia#Tamoxifen_monotherapy|Tamoxifen]] | ||
| style="background-color:#d73027" |Inferior frequency of epistaxis | | style="background-color:#d73027" |Inferior frequency of epistaxis | ||
|- | |- | ||
| − | |[https://doi.org/10. | + | |[https://doi.org/10.1111/jth.12654 Gaillard et al. 2014 (ATERO)] |
| + | |2006-09 to 2009-12 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Hereditary_hemorrhagic_telangiectasia#Tranexamic_acid_monotherapy|Tranexamic acid]] | |[[Hereditary_hemorrhagic_telangiectasia#Tranexamic_acid_monotherapy|Tranexamic acid]] | ||
| − | | style="background-color:# | + | | style="background-color:#d73027" |Longer mean duration of epistaxis |
|- | |- | ||
| − | |[https://doi.org/10. | + | |[https://doi.org/10.1001/jama.2016.11724 Whitehead et al. 2016 (NOSE)] |
| − | | style="background-color:#1a9851" |Phase | + | |2011-08 to 2014-03 |
| − | |[[Hereditary_hemorrhagic_telangiectasia#Tranexamic_acid_monotherapy|Tranexamic acid]] | + | | style="background-color:#1a9851" |Randomized Phase 2 (C) |
| − | | style="background-color:# | + | |1. [[#Bevacizumab_nasal_spray_999|Bevacizumab nasal spray]]<br>2. [[#Estriol_nasal_spray_999|Estriol nasal spray]]<br> 3. [[Hereditary_hemorrhagic_telangiectasia#Tranexamic_acid_monotherapy|Tranexamic acid]] |
| + | | style="background-color:#ffffbf" |Did not meet primary endpoint of epistaxis | ||
|- | |- | ||
| − | |[https:// | + | |[https://doi.org/10.1001/jama.2016.11387 Dupuis-Girod et al. 2016 (ALEGORI)] |
| + | |2014-04 to 2015-01 | ||
| style="background-color:#1a9851" |Randomized Phase 2 (C) | | style="background-color:#1a9851" |Randomized Phase 2 (C) | ||
|[[#Bevacizumab_nasal_spray_999|Bevacizumab nasal spray]] | |[[#Bevacizumab_nasal_spray_999|Bevacizumab nasal spray]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint | | style="background-color:#ffffbf" |Did not meet primary endpoint | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
|- | |- | ||
|} | |} | ||
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# '''TAHHT:''' Geisthoff UW, Seyfert UT, Kübler M, Bieg B, Plinkert PK, König J. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study. Thromb Res. 2014 Sep;134(3):565-71. Epub 2014 Jun 16. [https://doi.org/10.1016/j.thromres.2014.06.012 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25005464/ PubMed] [https://clinicaltrials.gov/study/NCT01031992 NCT01031992] | # '''TAHHT:''' Geisthoff UW, Seyfert UT, Kübler M, Bieg B, Plinkert PK, König J. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study. Thromb Res. 2014 Sep;134(3):565-71. Epub 2014 Jun 16. [https://doi.org/10.1016/j.thromres.2014.06.012 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25005464/ PubMed] [https://clinicaltrials.gov/study/NCT01031992 NCT01031992] | ||
# '''ATERO:''' Gaillard S, Dupuis-Girod S, Boutitie F, Rivière S, Morinière S, Hatron PY, Manfredi G, Kaminsky P, Capitaine AL, Roy P, Gueyffier F, Plauchu H; ATERO Study Group. Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European cross-over controlled trial in a rare disease. J Thromb Haemost. 2014 Sep;12(9):1494-502. Epub 2014 Jul 29. [https://doi.org/10.1111/jth.12654 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25040799/ PubMed] [https://clinicaltrials.gov/study/NCT00355108 NCT00355108] | # '''ATERO:''' Gaillard S, Dupuis-Girod S, Boutitie F, Rivière S, Morinière S, Hatron PY, Manfredi G, Kaminsky P, Capitaine AL, Roy P, Gueyffier F, Plauchu H; ATERO Study Group. Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European cross-over controlled trial in a rare disease. J Thromb Haemost. 2014 Sep;12(9):1494-502. Epub 2014 Jul 29. [https://doi.org/10.1111/jth.12654 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25040799/ PubMed] [https://clinicaltrials.gov/study/NCT00355108 NCT00355108] | ||
| − | # '''ALEGORI:''' Dupuis-Girod S, Ambrun A, Decullier E, Fargeton AE, Roux A, Bréant V, Colombet B, Rivière S, Cartier C, Lacombe P, Chinet T, Blivet S, Blondel JH, Gilbert-Dussardier B, Dufour X, Michel J, Harle JR, Dessi P, Faure F. Effect of Bevacizumab Nasal Spray on Epistaxis Duration in Hereditary Hemorrhagic Telangectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):934-42. [https:// | + | # '''ALEGORI:''' Dupuis-Girod S, Ambrun A, Decullier E, Fargeton AE, Roux A, Bréant V, Colombet B, Rivière S, Cartier C, Lacombe P, Chinet T, Blivet S, Blondel JH, Gilbert-Dussardier B, Dufour X, Michel J, Harle JR, Dessi P, Faure F. Effect of Bevacizumab Nasal Spray on Epistaxis Duration in Hereditary Hemorrhagic Telangectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):934-42. [https://doi.org/10.1001/jama.2016.11387 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27599328/ PubMed] [https://clinicaltrials.gov/study/NCT02106520 NCT02106520] |
| − | # '''NOSE:''' Whitehead KJ, Sautter NB, McWilliams JP, Chakinala MM, Merlo CA, Johnson MH, James M, Everett EM, Clancy MS, Faughnan ME, Oh SP, Olitsky SE, Pyeritz RE, Gossage JR. Effect of Topical Intranasal Therapy on Epistaxis Frequency in Patients With Hereditary Hemorrhagic Telangiectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):943-51. [https:// | + | # '''NOSE:''' Whitehead KJ, Sautter NB, McWilliams JP, Chakinala MM, Merlo CA, Johnson MH, James M, Everett EM, Clancy MS, Faughnan ME, Oh SP, Olitsky SE, Pyeritz RE, Gossage JR. Effect of Topical Intranasal Therapy on Epistaxis Frequency in Patients With Hereditary Hemorrhagic Telangiectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):943-51. [https://doi.org/10.1001/jama.2016.11724 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27599329/ PubMed] [https://clinicaltrials.gov/study/NCT01408030 NCT01408030] |
[[Category:Hereditary hemorrhagic telangiectasia regimens]] | [[Category:Hereditary hemorrhagic telangiectasia regimens]] | ||
Latest revision as of 01:10, 4 May 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 HHT page for regimens that include active treatment.
All lines of therapy
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Geisthoff et al. 2014 (TAHHT) | 2002-03-01 to 2002-05-31 | Phase 3 (C) | Tranexamic acid | Did not meet primary endpoint of hemoglobin levels1 |
| Yaniv et al. 2009 | 2005-02 to 2006-01 | Randomized Phase 2 (C) | Tamoxifen | Inferior frequency of epistaxis |
| Gaillard et al. 2014 (ATERO) | 2006-09 to 2009-12 | Phase 3 (C) | Tranexamic acid | Longer mean duration of epistaxis |
| Whitehead et al. 2016 (NOSE) | 2011-08 to 2014-03 | Randomized Phase 2 (C) | 1. Bevacizumab nasal spray 2. Estriol nasal spray 3. Tranexamic acid |
Did not meet primary endpoint of epistaxis |
| Dupuis-Girod et al. 2016 (ALEGORI) | 2014-04 to 2015-01 | Randomized Phase 2 (C) | Bevacizumab nasal spray | Did not meet primary endpoint |
1In TAHHT, the primary outcome of hemoglobin levels was not statistically significantly different, but the secondary outcome of epistaxis was inferior for this arm.
Note: No active treatment.
References
- Yaniv E, Preis M, Hadar T, Shvero J, Haddad M. Antiestrogen therapy for hereditary hemorrhagic telangiectasia: a double-blind placebo-controlled clinical trial. Laryngoscope. 2009 Feb;119(2):284-8. link to original article PubMed
- TAHHT: Geisthoff UW, Seyfert UT, Kübler M, Bieg B, Plinkert PK, König J. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study. Thromb Res. 2014 Sep;134(3):565-71. Epub 2014 Jun 16. link to original article PubMed NCT01031992
- ATERO: Gaillard S, Dupuis-Girod S, Boutitie F, Rivière S, Morinière S, Hatron PY, Manfredi G, Kaminsky P, Capitaine AL, Roy P, Gueyffier F, Plauchu H; ATERO Study Group. Tranexamic acid for epistaxis in hereditary hemorrhagic telangiectasia patients: a European cross-over controlled trial in a rare disease. J Thromb Haemost. 2014 Sep;12(9):1494-502. Epub 2014 Jul 29. link to original article PubMed NCT00355108
- ALEGORI: Dupuis-Girod S, Ambrun A, Decullier E, Fargeton AE, Roux A, Bréant V, Colombet B, Rivière S, Cartier C, Lacombe P, Chinet T, Blivet S, Blondel JH, Gilbert-Dussardier B, Dufour X, Michel J, Harle JR, Dessi P, Faure F. Effect of Bevacizumab Nasal Spray on Epistaxis Duration in Hereditary Hemorrhagic Telangectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):934-42. link to original article PubMed NCT02106520
- NOSE: Whitehead KJ, Sautter NB, McWilliams JP, Chakinala MM, Merlo CA, Johnson MH, James M, Everett EM, Clancy MS, Faughnan ME, Oh SP, Olitsky SE, Pyeritz RE, Gossage JR. Effect of Topical Intranasal Therapy on Epistaxis Frequency in Patients With Hereditary Hemorrhagic Telangiectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):943-51. link to original article PubMed NCT01408030