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All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

NCT01882127 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-04-20

No results posted yet for this study

Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of All-Trans Retinoic Acid (ATRA) combining with High-dose Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

Conditions

  • Purpura
  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

All-Trans Retinoid Acid(ATRA)

patients in ATRA\&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).

DRUG

Dexamethasone

Patients in High dose-DEX treatment group take dexamethasone( orally , 40mg daily for 4 days),patients in ATRA\&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).

Sponsors & Collaborators

  • Shandong University

    lead OTHER

Principal Investigators

  • Ming Hou, Dr · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-12-31

Countries

  • China

Study Locations

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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 NCT01882127 on ClinicalTrials.gov