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Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

NCT01734057 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL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 and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

Conditions

  • Purpura
  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

recombinant human thrombopoietin (rhTPO); rituximab

patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with rhTPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10\^9/L until the 28th day)

DRUG

Dexamethasone

Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.

Sponsors & Collaborators

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    collaborator OTHER

  • Anhui Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Shenzhen Second People's Hospital

    collaborator OTHER

  • China Medical University, China

    collaborator OTHER

  • Zhejiang Provincial Hospital of TCM

    collaborator OTHER

  • 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
2012-07-31
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • China

Study Locations

More Related Trials

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 NCT01734057 on ClinicalTrials.gov