Autoantibody Specificity and Response to IVIG in ITP

Shandong University672 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

672

Conditions

Immune Thrombocytopenia (ITP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

initial response

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.

Time frame: within 7 days of dosing

Data from ClinicalTrials.gov

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