NCT06004856

Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 195 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune Thrombocytopenia

Conditions

• Chronic Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	Orelabrutinib	Orelabrutinib once daily (QD)
DRUG	Placebo	Placebo once daily (QD)

Timeline

• Start date: 2023-10-26
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2023-08-22
• Last updated: 2024-05-13

Locations

45 sites across 1 country: China