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Completed

NCT Number: NCT01666795

Autoantibody Specificity and Response to IVIG in ITP

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Jinan Military General Hospital
  • Second Affiliated Hospital of Medical College Shandong University
  • Shandong University of Traditional Chinese Medicine
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2014
First posted
Aug 16, 2012
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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