CompletedNCT01666795Updated Apr 20, 2016

Autoantibody Specificity and Response to IVIG in ITP

An observational study in Immune Thrombocytopenia (ITP), sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-20.

Sponsored by Shandong University · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 672
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Immune Thrombocytopenia (ITP)

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In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's enrollment of 672 is above the median of 120 across 183 observational studies indexed under Thrombocytopenia.

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Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: 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

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
Enrollment: 672 participants (actual)

Groups and cohorts

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

What researchers measure

Primary outcomes

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.
Time frame: within 7 days of dosing

Study locations

1 site

Qilu Hospital, Shandong University
Jinan, Shandong 250012, China

References and documents

Publications

Peng J, Ma SH, Liu J, Hou Y, Liu XM, Niu T, Xu RR, Guo CS, Wang XM, Cheng YF, Ni H, Hou M. Association of autoantibody specificity and response to intravenous immunoglobulin G therapy in immune thrombocytopenia: a multicenter cohort study. J Thromb Haemost. 2014 Apr;12(4):497-504. doi: 10.1111/jth.12524. PubMed 24517219 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01666795
Lead sponsor: Shandong University
Collaborators: Second Affiliated Hospital of Medical College Shandong University, Jinan Military General Hospital, Shandong University of Traditional Chinese Medicine, West China Hospital
Responsible party: Ming Hou (Director, Department of Hematology, Qilu Hospital, Shandong University, Shandong University) — Principal investigator
First posted: Aug 16, 2012
Start date: Feb 2005
Primary completion: Jan 2013
Completion: Jan 2014
Last update: Apr 20, 2016

Study contacts

Ming Hou, MD

principal investigator · Qilu Hospital, Shandong University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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