Difference between revisions of "Thrombocytopenia in liver disease"

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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%"|Years 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#Comparative_efficacy|Comparative 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://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)]
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)]
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|2013-2017
 
| style="background-color:#1a9851" |Phase III (E-esc)
 
| style="background-color:#1a9851" |Phase III (E-esc)
 
|[[#Placebo|Placebo]]
 
|[[#Placebo|Placebo]]
 
| style="background-color:#1a9850" |Superior primary endpoint
 
| style="background-color:#1a9850" |Superior primary endpoint
 
|-
 
|-
−
|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)]
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|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)]
 +
|2014-2017
 
| style="background-color:#1a9851" |Phase III (E-esc)
 
| style="background-color:#1a9851" |Phase III (E-esc)
 
|[[#Placebo|Placebo]]
 
|[[#Placebo|Placebo]]
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 20%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Years of enrollment
−
!style="width: 25%"|Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
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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 1)]
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|2013-2014
 +
| style="background-color:#1a9851" |Phase III (E-esc)
 +
|[[#Placebo|Placebo]]
 +
| style="background-color:#1a9850" |Superior primary endpoint
 +
|-
 +
|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)]
 +
|2015-2017
 
| style="background-color:#1a9851" |Phase III (E-esc)
 
| style="background-color:#1a9851" |Phase III (E-esc)
 
|[[#Placebo|Placebo]]
 
|[[#Placebo|Placebo]]
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''Note: there are no apparent publications of these trials, to date.''
 
 
====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'''
 
===References===
 
===References===
−
# [https://clinicaltrials.gov/ct2/show/NCT02389621 CT.gov]
+
# '''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
 +
# '''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] NCT02389621
  
 
==Placebo==
 
==Placebo==
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|}
 
|}
 
===Regimen===
 
===Regimen===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 20%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Years of enrollment
−
!style="width: 25%"|Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 1)]
 +
|2013-2014
 +
| style="background-color:#1a9851" |Phase III (C)
 +
|[[#Lusutrombopag_monotherapy|Lusutrombopag]]
 +
| style="background-color:#d73027" |Inferior primary endpoint
 
|-
 
|-
−
|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1/ADAPT-2)]
+
|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-2)]
 +
|2013-2017
 +
| style="background-color:#1a9851" |Phase III (C)
 +
|[[#Avatrombopag_monotherapy|Avatrombopag]]
 +
| style="background-color:#d73027" |Inferior primary endpoint
 +
|-
 +
|[https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext Terrault et al. 2018 (ADAPT-1)]
 +
|2014-2017
 
| style="background-color:#1a9851" |Phase III (C)
 
| style="background-color:#1a9851" |Phase III (C)
 
|[[#Avatrombopag_monotherapy|Avatrombopag]]
 
|[[#Avatrombopag_monotherapy|Avatrombopag]]
 
| style="background-color:#d73027" |Inferior primary endpoint
 
| style="background-color:#d73027" |Inferior primary endpoint
 
|-
 
|-
−
|(L-PLUS 1/L-PLUS 2)
+
|[https://doi.org/10.1016/j.cgh.2020.03.032 Alkhouri et al. 2020 (L-PLUS 2)]
 +
|2015-2017
 
| style="background-color:#1a9851" |Phase III (C)
 
| style="background-color:#1a9851" |Phase III (C)
 
|[[#Lusutrombopag_monotherapy|Lusutrombopag]]
 
|[[#Lusutrombopag_monotherapy|Lusutrombopag]]
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''No active treatment.''
 
''No active treatment.''
 
===References===
 
===References===
−
# '''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://pubmed.ncbi.nlm.nih.gov/29778606 PubMed]
+
# '''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 Sep;155(3):705-718. Epub 2018 May 17. [https://www.gastrojournal.org/article/S0016-5085(18)34545-1/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/29778606 PubMed]
 +
# '''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
 +
# '''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] NCT02389621
  
 
[[Category:Thrombocytopenia in liver disease regimens]]
 
[[Category:Thrombocytopenia in liver disease regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Cytopenias]]
 
[[Category:Cytopenias]]

Revision as of 13:23, 12 December 2021

Page editor Section editor
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 Ronak H. Mistry, DO
Vanderbilt University
Nashville, TN
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 Benjamin Tillman, MD
Vanderbilt University
Nashville, TN

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

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Regimen

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

Growth factor therapy

  • Avatrombopag (Doptelet) as follows:
    • Platelet count less than 40 x 109/L: 60 mg PO once per day on days 1 to 5
    • Platelet count at least 40 and less than 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

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Regimen

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

Placebo

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Alkhouri et al. 2020 (L-PLUS 1) 2013-2014 Phase III (C) Lusutrombopag Inferior primary endpoint
Terrault et al. 2018 (ADAPT-2) 2013-2017 Phase III (C) Avatrombopag Inferior primary endpoint
Terrault et al. 2018 (ADAPT-1) 2014-2017 Phase III (C) Avatrombopag Inferior primary endpoint
Alkhouri et al. 2020 (L-PLUS 2) 2015-2017 Phase III (C) Lusutrombopag Inferior primary endpoint

No active treatment.

References

  1. 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 Sep;155(3):705-718. Epub 2018 May 17. link to original article PubMed
  2. 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
  3. 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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