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

NCT06004856 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2024-05-13

No results posted yet for this study

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

DRUG

Orelabrutinib

Orelabrutinib once daily (QD)

DRUG

Placebo

Placebo once daily (QD)

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06004856 on ClinicalTrials.gov