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Autoantibody Specificity and Response to IVIG in ITP

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

NCT01666795•Shandong University

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Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

February 1, 2005

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2014

Last Updated

April 20, 2016

Enrollment

672

ACTUAL participants

Conditions

Immune Thrombocytopenia (ITP)

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

NCT07294365

Immune Thrombocytopenia (ITP)

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RECRUITINGPHASE1/PHASE2

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

NCT07175493

Autoimmune CytopeniaImmune Thrombocytopenia (ITP)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Autoantibody Specificity and Response to IVIG in ITP

Inclusion Criteria

Exclusion Criteria

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

Safety Study of CC312 in Autoimmune Disease Patients

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia