Autoantibody Specificity and Response to IVIG in ITP

NCT01666795 | Completed DMC

• 1 other identifier: ITP-006
• Study Type: observational
• Target: 672
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

IVIG therapy in ITP

IVIG therapy in untreated adults with severe ITP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• (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.

You may not qualify if:

• a history of any ITP-specific treatment administered prior to or concomitantly with the IVIG

Sponsors & Collaborators

• Shandong University: lead
• Second Affiliated Hospital of Medical College Shandong University: collaborator
• Jinan Military General Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• West China Hospital: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• 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.

  PMID: 24517219 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ming Hou, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Hematology, Qilu Hospital, Shandong University

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: February 1, 2005
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: April 20, 2016

Record last verified: 2012-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)