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

Sponsor
Ming Hou
Study ID
NCT01506414
Phase
PHASE3
Status
Completed

Conditions

  • Idiopathic Thrombocytopenic Purpura
  • Purpura

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rhTPO in combination with Rituximab — DRUG
    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).

Study Details

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).

Key Dates

Start date
Jun 30, 2009
Status verified
Jan 2012
Primary completion
Aug 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
91 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combination treatment

Primary Outcome Measure

Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]