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Avatrombopag in Japanese Adults with Chronic Immune Thrombocytopenia
jRCT2031220005Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2022
- Countries
- 1
- Sponsor
- Sobi
- Modality
- Small Molecules
- Drugs
- avatrombopag
- Conditions
- immune thrombocytopenia (ITP)
01
Overview
Phase 3, open-label, single-arm trial of avatrombopag in immune thrombocytopenia (ITP), sponsored by Sobi. Primary endpoint: Cumulative weeks with platelet count ≥50×10^9/L without rescue therapy during core phase. Started Jun 2022; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Avatrombopag monotherapy
All enrolled subjects receive avatrombopag with an initial dose of 20 mg once daily and subsequent individualized dose/frequency adjustments based on platelet counts.
03
Who it enrols
Adults (≥18 years) with confirmed chronic immune thrombocytopenia of at least 12 months' duration, with insufficient response to at least one prior ITP treatment and baseline platelet counts <30×10^9/L on average (no single count >35×10^9/L). Excludes secondary immune thrombocytopenia (e.g., H. pylori-induced, HIV- or HCV-associated, systemic lupus erythematosus), inherited thrombocytopenia, and hereditary thrombophilic disorders.
04
Endpoints
Primary
Cumulative weeks with platelet count ≥50×10^9/L without rescue therapy during core phase
Secondary
Platelet response rate at Day 8
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