Thrombocytopenia in chronic liver disease: Physiopathology and new therapeutic strategies before invasive procedures

Table 1 ADAPT 1-2 key characteristics

Key characteristic	ADAPT 1-2
Key inclusion criteria	Chronic liver disease (MELD score ≤ 24) and thrombocytopenia (platelet counts < 50000/μL). Age ≥ 18 yr
Key exclusion criteria	ADAPT-1/2: History of thrombosis or hematologic disorders. Significant cardiovascular disease. Portal or splenic mesenteric system thrombosis at screening; portal vein blood flow < 10 cm/s at screening. Platelet transfusion within 7 d of screening. Use of heparin, warfarin, FANS, aspirin, verapamil, or antiplatelet therapy with ticlopidine or glycoprotein IIb/IIIa antagonists, or erythropoietin-stimulating agents within 7 d of screening. Advanced hepatocellular carcinoma (BCLC C or D)
Dosing	Low baseline platelet count cohort (≤ 40000/μL): 60 mg avatrombopag or placebo once daily with a meal on days 1-5. High baseline platelet count cohort (40000-50000/μL): 40 mg avatrombopag or placebo once daily with a meal on days 1-5
Type of study	ADAPT-1/2: Global, multicenter, randomized, double-blind, placebo- controlled, phase 3 studies
Patients number	ADAPT-1: 231; ADAPT-2: 204
Endpoints	Efficacy assessment: (1) Primary: Proportion of patients not requiring a platelet transfusion or rescue procedure for bleeding bleeding in the 7 d after the procedures; and (2) Secondary: Proportion of patients achieving the target platelet count of 50000/μL on procedure day; the change in platelet count from baseline to procedure day. Safety assessment: The incidence of adverse events adverse drug reactions, treatment-emergent adverse events

MELD: Model for end-stage liver disease.