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A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia

NCT06900920 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2025-05-20

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled Phase III clinical study designed to demonstrate that TQB3473 tablets significantly improve the sustained response rate compared to placebo in adult patients with chronic ITP who have previously received standard corticosteroid therapy and have failed or relapsed after at least one standard ITP treatment.

The study consists of a treatment period and a safety follow-up period.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

DRUG

TQB3473 Tablets

TQB3473 tablet is a selective Spleen tyrosine kinase (Syk) inhibitor.

DRUG

TQB3473 Placebo

Placebo contains no active substance.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06900920 on ClinicalTrials.gov