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The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

NCT04217148 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-09-28

No results posted yet for this study

Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of ATRA plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Conditions

Interventions

DRUG

Dexamethasone

Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)

DRUG

ATRA

ATRA, po,10mg bid, for 12 weeks

Sponsors & Collaborators

  • Beijing Hospital

    collaborator OTHER_GOV

  • Navy General Hospital, Beijing

    collaborator OTHER

  • Beijing Aerospace General Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Beijing Tongren Hospital

    collaborator OTHER

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04217148 on ClinicalTrials.gov