MedTrace Logo

rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP

NCT01525836 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

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 refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.

Conditions

  • Purpura
  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

rituximab; recombinant human thrombopoietin (rhTPO)

patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( 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 29th day)

DRUG

Rituximab

patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)

Sponsors & Collaborators

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

    collaborator OTHER

  • The First Affiliated Hospital of 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

  • First Hospital of China Medical University

    collaborator OTHER

  • Shandong University

    lead OTHER

Principal Investigators

  • Minf Hou, Dr. · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-12-31
Completion
2014-06-30

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 NCT01525836 on ClinicalTrials.gov