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

Sponsors

Lead Sponsor: Shandong University

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

Source Shandong University
Brief 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.

Overall Status Completed
Start Date February 2005
Completion Date January 2014
Primary Completion Date January 2013
Study Type Observational
Primary Outcome
Measure Time Frame
initial response within 7 days of dosing
Enrollment 672
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ming Hou, MD Principal Investigator Qilu Hospital, Shandong University
Location
Facility: Qilu Hospital, Shandong University
Location Countries

China

Verification Date

August 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Director, Department of Hematology, Qilu Hospital, Shandong University

Has Expanded Access No
Condition Browse
Arm Group

Label: IVIG therapy in ITP

Description: IVIG therapy in untreated adults with severe ITP

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov