Thrombocytopenia in liver disease - null regimens

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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 thrombocytopenia in liver disease page for regimens that include active treatment.


Thrombocytopenia in liver disease with planned procedure

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Alkhouri et al. 2020 (L-PLUS 1) 2013-10 to 2014-05 Phase 3 (C) Lusutrombopag Inferior primary endpoint
Terrault et al. 2018 (ADAPT-2) 2013-2017 Phase 3 (C) Avatrombopag Inferior primary endpoint
Terrault et al. 2018 (ADAPT-1) 2014-2017 Phase 3 (C) Avatrombopag Inferior primary endpoint
Alkhouri et al. 2020 (L-PLUS 2) 2015-2017 Phase 3 (C) Lusutrombopag Inferior primary endpoint

No active treatment.

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
  3. 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
  4. 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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