Clinical Trial: A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITPᦀ

Brief Summary: The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of recombinant human thrombopoietin combining with cyclosporin A for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.

Detailed Summary: The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 120 steroid-resistant/relapsed ITP adult patients from 6 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 29th day), combining with cyclosporin A (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). The others are selected to receive cyclosporin A monotherapy (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to cyclosporin A monotherapy for the treatment of adults with steroid-resistant/relapsed ITP.
Sponsor: Shandong University

Current Primary Outcome:

  • Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]
    CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L
  • Evaluation of platelet response (Response) [ Time Frame: The time frame is up to 3 months per subject ]
    R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
  • Evaluation of platelet response (No Response) [ Time Frame: The time frame is up to 3 months per subject ]
    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.
  • Evaluation of platelet response (relapses) [ Time Frame: The time frame is up to 3 months per subject ]
    A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.


Original Primary Outcome: Same as current

Current Secondary Outcome: The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events [ Time Frame: up to 3 months per subject ]

Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: July 27, 2014
Date Started: July 2014
Date Completion:
Last Updated: April 18, 2016
Last Verified: July 2014