Autoantibody Specificity and Response to IVIG in ITP

Immune Thrombocytopenia (ITP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666795
• Other study ID #: ITP-006
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: April 18, 2016
• Start date: February 2005
• Est. completion date: January 2014

Study information

• Verified date: August 2012
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Qilu Hospital, Shandong Univ.
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Immune Thrombocytopenia (ITP)
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 7 days of dosing	No