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Autoantibody Specificity and Response to IVIG in ITP

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ClinicalTrials.gov Identifier: NCT01666795
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Immune Thrombocytopenia (ITP)

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.

Study Design

Study Type : Observational
Actual Enrollment : 672 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Autoantibody Specificity and Response to Intravenous Immunoglobulin G (IVIG) in Immune Thrombocytopenia (ITP): a Retrospective Cohort Study
Study Start Date : February 2005
Primary Completion Date : January 2013
Study Completion Date : January 2014

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients with severe ITP who underwent IVIG therapy and had platelet autoantibodies assayed

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666795

China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Second Affiliated Hospital of Medical College Shandong University
Jinan Military General Hospital
Shandong University of Traditional Chinese Medicine
West China Hospital
Principal Investigator: Ming Hou, MD Qilu Hospital, Shandong University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ming Hou, Director, Department of Hematology, Qilu Hospital, Shandong University, Shandong University
ClinicalTrials.gov Identifier: NCT01666795     History of Changes
Other Study ID Numbers: ITP-006
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: August 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Immunologic Factors
Physiological Effects of Drugs