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Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)

NCT01506414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2016-04-20

No results posted yet for this study

Summary

The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO) in combination with Rituximab are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).

Conditions

  • Purpura
  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

rhTPO in combination with Rituximab

Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14).

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Zhejiang University

    collaborator OTHER

  • Ming Hou

    lead OTHER

Principal Investigators

  • Hou Ming, Dr. · Shandong University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • China

Study Locations

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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 NCT01506414 on ClinicalTrials.gov