Autoantibody Specificity and Response to IVIG in ITP

Sponsor

Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT01666795

Collaborator

Second Affiliated Hospital of Medical College Shandong University (Other), Jinan Military General Hospital (Other), Shandong University of Traditional Chinese Medicine (Other), West China Hospital (Other)

672

Enrollment

Location

107

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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 :

Feb 1, 2005

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
IVIG therapy in ITP IVIG therapy in untreated adults with severe ITP

Outcome Measures

Primary Outcome Measures

initial response [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

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

Principal Investigator: Ming Hou, MD, Qilu Hospital, Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ming Hou, Director, Department of Hematology, Qilu Hospital, Shandong University, Shandong University

ClinicalTrials.gov Identifier:

NCT01666795

Other Study ID Numbers:

ITP-006

First Posted:

Aug 16, 2012

Last Update Posted:

Apr 20, 2016

Last Verified:

Aug 1, 2012

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Apr 20, 2016