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Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP

NCT07057778 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-10

No results posted yet for this study

Summary

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.

Conditions

  • Immune Thrombocytopenia (ITP)

Interventions

DRUG

Iguratimod

oral iguratimod at 25mg twice daily for 26 weeks

DRUG

low-dose rituximab

rituximab 100mg once weekly for 6 weeks

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • Beijing Friendship Hospital

    collaborator OTHER

  • Navy General Hospital, Beijing

    collaborator OTHER

  • Beijing Tongren Hospital

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiaohui Zhang · Peking University Institute of Hematology, Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-30
Completion
2027-07-01

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 NCT07057778 on ClinicalTrials.gov