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).
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). Platelet count (PC) was monitored every three or four days until day 22, followed by tests every week. Platelet transfusion was administered to patients with active bleeding symptoms or to those whose PC\<10×10\^9/L. Patients were followed for 3 months, and any adverse effects were recorded during the period of treatment and during the follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
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).
Qilu Hospital, Shandong University
Jinan, Shandong, China
Evaluation of platelet response (Complete Response)
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L without recurrence of thrombocytopenia
Time frame: The time frame is up to 3 months per subject
Evaluation of platelet response (R)
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia
Time frame: The time frame is up to 3 months per subject
Evaluation of platelet response (No Response)
NR.No response (NR) was defined as platelet count \< 30 × 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Time frame: The time frame is up to 3 months per subject
The number and frequency of therapy associated adverse events
Time frame: up to 3 months per subject
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