Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP

NCT03252457 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-08-15

No results posted yet for this study

Summary

The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known hospitals in China. In order to report the efficacy and safety of decitabine combining with dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .

Conditions

Interventions

DRUG

Decitabine

given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles

DRUG

Dexamethasone

given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.

Sponsors & Collaborators

  • Second Affiliated Hospital of Medical College Shandong University

    collaborator OTHER
  • Shandong Provincial Hospital

    collaborator OTHER_GOV
  • Qingdao Central Hospital

    collaborator OTHER
  • Chinese Academy of Medical Sciences

    collaborator OTHER
  • Shandong University

    lead OTHER

Principal Investigators

  • Ming Hou, Dr · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-12-01
Completion
2021-12-01

Countries

  • China

Study Locations

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Entities

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 NCT03252457 on ClinicalTrials.gov