Autoantibody Specificity and Response to IVIG in ITP

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Shandong University.
Recruitment status was  Recruiting
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: October 31, 2012
Last verified: August 2012
  Purpose

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.


Condition
Immune Thrombocytopenia (ITP)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: February 2005
Groups/Cohorts
IVIG therapy in ITP
IVIG therapy in untreated adults with severe ITP

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adult patients with severe ITP who underwent IVIG therapy and had platelet autoantibodies assayed

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666795

Contacts
Contact: Jun Peng, MD 8613553157577 junpeng88@sina.com.cn

Locations
China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Principal Investigator: Ming Hou, MD         
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
  More Information

No publications provided by Shandong University

Additional 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
Study First Received: August 14, 2012
Last Updated: October 31, 2012
Health Authority: China:Qilu Hospital, Shandong Univ.

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Autoantibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014