Autoantibody Specificity and Response to IVIG in ITP

This study has been completed.
Sponsor:
Collaborators:
Second Affiliated Hospital of Medical College Shandong University
Jinan Military General Hospital
Shandong University of Traditional Chinese Medicine
West China Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01666795
First received: August 14, 2012
Last updated: April 18, 2016
Last verified: August 2012

August 14, 2012
April 18, 2016
February 2005
January 2013   (final data collection date for primary outcome measure)
initial response [ Time Frame: within 7 days of dosing ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01666795 on ClinicalTrials.gov Archive Site
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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
The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample
adult patients with severe ITP who underwent IVIG therapy and had platelet autoantibodies assayed
Immune Thrombocytopenia (ITP)
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IVIG therapy in ITP
IVIG therapy in untreated adults with severe ITP
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
672
January 2014
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01666795
ITP-006
Yes
No
Not Provided
Ming Hou, Shandong University
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
Shandong University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP