Autoantibody Specificity and Response to IVIG in ITP

Overview

The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.

Full Title of Study: “Autoantibody Specificity and Response to Intravenous Immunoglobulin G (IVIG) in Immune Thrombocytopenia (ITP): a Retrospective Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 2013

Detailed Description

Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.

Arms, Groups and Cohorts

  • IVIG therapy in ITP
    • IVIG therapy in untreated adults with severe ITP

Clinical Trial Outcome Measures

Primary Measures

  • initial response
    • Time Frame: within 7 days of dosing
    • The criteria for an initial response was a platelet count ≥ 30 × 109/L and doubling of the baseline count within 7 days of dosing (confirmed on at least 2 separate occasions at least 7 days apart), and absence of bleeding.

Participating in This Clinical Trial

Inclusion Criteria

  • (1) the diagnosis of ITP was based on the presence of isolated thrombocytopenia and the absence of any obvious initiating and/or underlying cause of the thrombocytopenia in accordance with the recently released international consensus guidelines,(2) a diagnosis was established during the 4 weeks prior to initiation of IVIG treatment, (3) age ≥ 18 years, (4) a platelet count of ≤ 20 × 109/L, and (5) a bleeding score ≥ 9 at the time of admission according to the clinical scoring system described by Khellaf et al. to assess the severity of hemorrhage. Exclusion Criteria:

  • a history of any ITP-specific treatment administered prior to or concomitantly with the IVIG

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong University
  • Collaborator
    • Second Affiliated Hospital of Medical College Shandong University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ming Hou, Director, Department of Hematology, Qilu Hospital, Shandong University – Shandong University
  • Overall Official(s)
    • Ming Hou, MD, Principal Investigator, Qilu Hospital, Shandong University

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