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The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9

NCT05438875 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-09-09

No results posted yet for this study

Summary

A Prospective, Randomized, Open-Label, Multicenter Clinical Trial study to compare the efficacy and safety of ATRA plus eltrombopag compared to eltrombopag monotherapy in the treatment of steroid-resistant/relapsed immune thrombocytopenia (ITP).

Conditions

  • Purpura, Thrombocytopenic, Idiopathic

Interventions

DRUG

all-trans retinoic acid

ATRA 10 mg, 2 times a day, orally.The treatment course is 12 weeks.

DRUG

Eltrombopag

The initial dose of eltrombopag is 50 mg/time, once a day, and the dose is increased when the platelet count is lower than 5×109/L, the maximum is 75 mg/d, and the dose is higher than 200×109/L. When the drug is temporarily discontinued, the drug is re-administered according to the platelet count.The treatment course is 12 weeks.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    collaborator OTHER

  • Beijing Tongren Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Navy General Hospital, Beijing

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiaohui Zhang, MD · Study Principal Investigator Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2024-11-30
Completion
2024-11-30

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 NCT05438875 on ClinicalTrials.gov