Difference between revisions of "Thrombocytopenia in liver disease"

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!colspan="4" align="center" style="color:white; font-size:125%; background-color:#31a354"|'''Section editors'''
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|style="background-color:#F0F0F0; width:15%"|[[File:Shruti.jpg|frameless|upright=0.3|center]]
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|style="width:35%"|<big>[[User:Shrutichaturvedi|Shruti Chaturvedi, MBBS, MSCI]]<br>Johns Hopkins University<br>Baltimore, MD</big><br>[https://www.linkedin.com/in/shruti-chaturvedi-bb83b126/ LinkedIn]
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|style="background-color:#F0F0F0; width:15%"|[[File:Tillman_Benjamin-2.jpg|frameless|upright=0.3|center]]
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''Are you looking for a regimen, but can't find it here? For placebo or observational studies in this condition, please visit [[Thrombocytopenia in liver disease - null regimens|this page]]. If you still can't find it, please let us know so we can add it!''<br>
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|style="width:35%"|<big>[[User:Benjamintillman|Benjamin Tillman, MD]]<br>Vanderbilt University<br>Nashville, TN</big>
 
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See the [[Thrombocytopenia|thrombocytopenia reference page]] for general definitions and workup recommendations.
 
See the [[Thrombocytopenia|thrombocytopenia reference page]] for general definitions and workup recommendations.
 
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{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=Thrombocytopenia in liver disease with planned procedure=
 
=Thrombocytopenia in liver disease with planned procedure=
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==Avatrombopag monotherapy {{#subobject:7c8c62|Regimen=1}}==
 
==Avatrombopag monotherapy {{#subobject:7c8c62|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
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|[[#top|back to top]]
 
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===Regimen {{#subobject:666055|Variant=1}}===
 
===Regimen {{#subobject:666055|Variant=1}}===
 
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{| class="wikitable" style="color:white; background-color:#404040"
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|-
 
|}
 
|}
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{| class="wikitable" style="width: 100%; text-align:center;"
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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!style="width: 25%"|Study
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!style="width: 20%"|Study
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Dates of enrollment
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!style="width: 25%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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|-
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|[https://doi.org/10.1053/j.gastro.2018.05.025 Terrault et al. 2018 (ADAPT-2)]
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|2013-2017
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| style="background-color:#1a9851" |Phase 3 (E-esc)
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|[[Thrombocytopenia_in_liver_disease_-_null_regimens#Placebo|Placebo]]
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| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1/ADAPT-2)]
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|[https://doi.org/10.1053/j.gastro.2018.05.025 Terrault et al. 2018 (ADAPT-1)]
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| style="background-color:#1a9851" |Phase III (E)
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|2014-2017
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|[[#Placebo|Placebo]]
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| style="background-color:#1a9851" |Phase 3 (E-esc)
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|[[Thrombocytopenia_in_liver_disease_-_null_regimens#Placebo|Placebo]]
 
| style="background-color:#1a9850" |Superior primary endpoint
 
| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
 
|}
 
|}
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Growth factor therapy====
 
====Growth factor therapy====
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*[[Avatrombopag (Doptelet)]] as follows:
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*[[Avatrombopag (Doptelet)]] by the following laboratory-based criteria:
 
**Platelet count less than 40 x 10<sup>9</sup>/L: 60 mg PO once per day on days 1 to 5
 
**Platelet count less than 40 x 10<sup>9</sup>/L: 60 mg PO once per day on days 1 to 5
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**Platelet count at least 40 and less than 50 x 10<sup>9</sup>/L: 40 mg PO once per day on days 1 to 5
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**Platelet count 40 up to 50 x 10<sup>9</sup>/L: 40 mg PO once per day on days 1 to 5
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'''Procedure days were days 10 to 13'''
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</div></div>
  
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'''Procedure days were days 10 to 13'''
 
 
===References===
 
===References===
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# '''ADAPT-1/ADAPT-2:''' Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 May 17. [Epub ahead of print] [https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29778606 PubMed]
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# '''ADAPT-1:''' Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. [https://doi.org/10.1053/j.gastro.2018.05.025 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606/ PubMed] [https://clinicaltrials.gov/study/NCT01972529 NCT01972529]
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# '''ADAPT-2:''' Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. [https://doi.org/10.1053/j.gastro.2018.05.025 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606/ PubMed] [https://clinicaltrials.gov/study/NCT01976104 NCT01976104]
 
==Lusutrombopag monotherapy {{#subobject:8f4acd|Regimen=1}}==
 
==Lusutrombopag monotherapy {{#subobject:8f4acd|Regimen=1}}==
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|[[#top|back to top]]
 
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===Regimen {{#subobject:4c9447|Variant=1}}===
 
===Regimen {{#subobject:4c9447|Variant=1}}===
 
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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!style="width: 25%"|Study
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!style="width: 20%"|Study
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Dates of enrollment
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!style="width: 25%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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|-
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|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 1)]
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|2013-10 to 2014-05
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| style="background-color:#1a9851" |Phase 3 (E-esc)
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|[[Thrombocytopenia_in_liver_disease_-_null_regimens#Placebo|Placebo]]
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| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
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|(L-PLUS 1/L-PLUS 2)
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|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)]
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| style="background-color:#1a9851" |Phase III (E)
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|2015-2017
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|[[#Placebo|Placebo]]
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| style="background-color:#1a9851" |Phase 3 (E-esc)
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|[[Thrombocytopenia_in_liver_disease_-_null_regimens#Placebo|Placebo]]
 
| style="background-color:#1a9850" |Superior primary endpoint
 
| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
 
|}
 
|}
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''Note: there are no apparent publications of these trials, to date.''
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Growth factor therapy====
 
====Growth factor therapy====
 
*[[Lusutrombopag (Mulpleta)]] 3 mg PO once per day on days 1 to 7
 
*[[Lusutrombopag (Mulpleta)]] 3 mg PO once per day on days 1 to 7
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'''7-day course'''
 
'''7-day course'''
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</div></div>
 
===References===
 
===References===
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# [https://clinicaltrials.gov/ct2/show/NCT02389621 CT.gov]
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# '''L-PLUS 1:''' Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. [https://doi.org/10.1016/j.cgh.2020.03.032 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32205226/ PubMed] JapicCTI-132323
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# '''L-PLUS 2:''' Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. [https://doi.org/10.1016/j.cgh.2020.03.032 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32205226/ PubMed] [https://clinicaltrials.gov/study/NCT02389621 NCT02389621]
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==Placebo==
 
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===Regimen===
 
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{| class="wikitable" style="width: 100%; text-align:center;"
 
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!style="width: 25%"|Study
 
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 25%"|Comparator
 
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1/ADAPT-2)]
 
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| style="background-color:#1a9851" |Phase III (C)
 
−
|[[#Avatrombopag_monotherapy|Avatrombopag]]
 
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| style="background-color:#d73027" |Inferior primary endpoint
 
−
|-
 
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|(L-PLUS 1/L-PLUS 2)
 
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| style="background-color:#1a9851" |Phase III (C)
 
−
|[[#Lusutrombopag_monotherapy|Lusutrombopag]]
 
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| style="background-color:#d73027" |Inferior primary endpoint
 
−
|-
 
−
|}
 
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''No active treatment.''
 
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===References===
 
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# '''ADAPT-1/ADAPT-2:''' Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 May 17. [Epub ahead of print] [https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/29778606 PubMed]
 
  
 
[[Category:Thrombocytopenia in liver disease regimens]]
 
[[Category:Thrombocytopenia in liver disease regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Cytopenias]]
 
[[Category:Cytopenias]]

Latest revision as of 23:56, 15 May 2024

Back to Top

Section editor
Tillman Benjamin-2.jpg
 Benjamin Tillman, MD
Vanderbilt University
Nashville, TN, USA
LinkedIn

Are you looking for a regimen, but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
See the thrombocytopenia reference page for general definitions and workup recommendations.

2 regimens on this page
2 variants on this page


Thrombocytopenia in liver disease with planned procedure

Avatrombopag monotherapy

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence Comparator Comparative Efficacy
Terrault et al. 2018 (ADAPT-2) 2013-2017 Phase 3 (E-esc) Placebo Superior primary endpoint
Terrault et al. 2018 (ADAPT-1) 2014-2017 Phase 3 (E-esc) Placebo Superior primary endpoint

Growth factor therapy

  • Avatrombopag (Doptelet) by the following laboratory-based criteria:
    • Platelet count less than 40 x 109/L: 60 mg PO once per day on days 1 to 5
    • Platelet count 40 up to 50 x 109/L: 40 mg PO once per day on days 1 to 5

Procedure days were days 10 to 13

References

  1. ADAPT-1: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed NCT01972529
  2. ADAPT-2: Terrault N, Chen YC, Izumi N, Kayali Z, Mitrut P, Tak WY, Allen LF, Hassanein T. Avatrombopag before procedures reduces need for platelet transfusion in patients with chronic liver disease and thrombocytopenia. Gastroenterology. 2018 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed NCT01976104

Lusutrombopag monotherapy

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence Comparator Comparative Efficacy
Alkhouri et al. 2020 (L-PLUS 1) 2013-10 to 2014-05 Phase 3 (E-esc) Placebo Superior primary endpoint
Alkhouri et al. 2020 (L-PLUS 2) 2015-2017 Phase 3 (E-esc) Placebo Superior primary endpoint

Growth factor therapy

7-day course

References

  1. L-PLUS 1: Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. link to original article PubMed JapicCTI-132323
  2. L-PLUS 2: Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. Epub 2020 Mar 20. link to original article PubMed NCT02389621
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