ADAPT-1 PHASE3 COMPLETED n=231
Drug: Doptelet · SOBI
Study Design
DesignRandomized, double-blind, placebo-controlled
Randomization2:1 within cohorts
BlindingDouble-blind
Enrollment231
Duration2 weeks
Treatment Arms
Avatrombopag 60 mg (low plt) 60 mg/day x 5 days (baseline plt <40K) n=90
Placebo (low plt) Placebo x 5 days n=48
Avatrombopag 40 mg (high plt) 40 mg/day x 5 days (baseline plt 40-<50K) n=59
Placebo (high plt) Placebo x 5 days n=34
Primary Endpoints
[{"id":"adapt1-ep1","name":"Proportion NOT requiring platelet transfusion or rescue for bleeding","type":"PRIMARY","p_value":"<0.0001 (both cohorts)","results":[{"n":"59/90","arm":"adapt1-60","label":"65.6% (low plt cohort)","value":65.6},{"n":"11/48","arm":"adapt1-pbo-lo","label":"22.9% (placebo)","value":22.9},{"n":"52/59","arm":"adapt1-40","label":"88.1% (high plt cohort)","value":88.1},{"n":"13/34","arm":"adapt1-pbo-hi","label":"38.2% (placebo)","value":38.2}],"description":"Patients with chronic liver disease (CLD) often need procedures but have low platelets due to liver dysfunction. Avatrombopag raises platelets enough to safely proceed without needing a platelet transfusion - avoiding transfusion-associated risks and costs."}]
Safety Results
AE incidence similar between avatrombopag and placebo. No hepatotoxicity signal. No increase in thromboembolic events. No bleeding events increase. No rebound thrombocytopenia. Portal vein thrombosis: 0.4% (1/274 avatrombopag-treated).
Assessment
CLD thrombocytopenia is the bread-and-butter indication for Doptelet. Clean safety profile differentiated from competitor. This is steady revenue, not a growth driver.
Background & Context
TPO receptor agonist that raises platelet counts in CLD patients prior to scheduled procedures. Short-course (5 days) with no food requirement and no hepatotoxicity - key differentiators vs lusutrombopag.
Data from Supabase · Updated 2026-03-24