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Completed Phase 3 Interventional Results available

IGIV Study for Chronic ITP Patients Ages 3-70

ClinicalTrials.gov ID: NCT00511147

Public ClinicalTrials.gov record NCT00511147. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:52 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic Purpura

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Idiopathic (immune) thrombocytopenic purpura (ITP) is an autoimmune disorder characterized by platelet destruction and thrombocytopenia (peripheral blood platelet count \< 150 x 10\^9/L). IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs, or where bleeding is predicted (e.g., surgery or parturition). The primary goal of treatment is to maintain the platelet count at a hemostatic level. This study will test the safety and efficacy of IGIV3I Grifols 10% in the treatment of patients with chronic ITP.

Study identification

NCT ID
NCT00511147
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Grifols Biologicals, LLC
Industry
Enrollment
64 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
3 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2008
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014
Last update posted
Jun 11, 2017

2008 – 2014

United States locations

U.S. sites
31
U.S. states
18
U.S. cities
29
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85061
Scottsdale Medical Specialists Scottsdale Arizona 85258
Arizona Oncology Associates Tucson Arizona 85745
Scripps Cancer Center La Jolla California 92037
Kenmar Research Institute, LLC Los Angeles California 90057
Children's Hospital of Orange County Orange California 92868
Connecticut Children's Medical Center Hartford Connecticut 06106
Cancer Center of Central Connecticut Southington Connecticut 06489
Georgetown University Washington D.C. District of Columbia 20007
VA Medical Center Washington D.C. District of Columbia 20422
Halifax Health Medical Center Daytona Beach Florida 32114
Hematology Oncology Associates Lake Worth Florida 33461
Lakeland Regional Cancer Center Tampa Florida 33607-6307
St. Joseph's Children's Hospital of Tampa Tampa Florida 33607-6307
Cleveland Clinic Florida Weston Florida 33331
Emory University School of Medicine Winship Cancer Center Atlanta Georgia 30322
Advocate Hope Children's Hospital Oak Lawn Illinois 60453
University of Iowa Children's Hospital Iowa City Iowa 52242
Children's Hospital New Orleans Louisiana 70118
Kalamazoo Hematology & Oncology Kalamazoo Michigan 49048
CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute Lansing Michigan 48910
University of Mississippi Jackson Mississippi 39216
Capital Comprehensive Cancer Care Clinic Jefferson City Missouri 65109
UMDNJ-RWJ Medical School New Brunswick New Jersey 08901
Mt. Sinai Medical Center New York New York 10029
Children's Hospital, University of Oklahoma Oklahoma City Oklahoma 73104
Western Pennsylvannia Hospital Pittsburgh Pennsylvania 15224
Baptist Cancer Center Beaumont Texas 77705
Cook Children's Medical Center Fort Worth Texas 76104
Tyler Hematology Oncology PA Tyler Texas 75701
MCV Hospital Richmond Virginia 23298

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00511147, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 11, 2017 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00511147 live on ClinicalTrials.gov.

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