Autoantibody Specificity and Response to IVIG in ITP
This study is currently recruiting participants.
Verified August 2012 by Shandong University
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
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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
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
| 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 May 19, 2013