Clinical Trial: Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia

Brief Summary: The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).

Detailed Summary:
Sponsor: Ming Hou

Current Primary Outcome: Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 14 days per subject ]

CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluation of platelet response (R) [ Time Frame: The time frame is up to 14 days per subject ]
    R. A response (R) was defined as a sustained (≥ 4 months) platelet count ≥ 30×109/L without recurrence of thrombocytopenia
  • The time of rhIL-11 onset. [ Time Frame: The time frame is up to 28 days per subject. ]
    The time to platelet recovery (defined as the number of days from the start of the study to the first day with a platelet count of ≥30 × 109/L)
  • DFS [ Time Frame: The time frame is up to 90 days per subject. ]
    The median disease-free survival periods
  • The number and frequency of IL-11 associated adverse events. [ Time Frame: up to 14 days per subject ]


Original Secondary Outcome: Same as current

Information By: Shandong University

Dates:
Date Received: March 17, 2011
Date Started: March 2011
Date Completion: March 2012
Last Updated: April 18, 2016
Last Verified: November 2011