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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 Oct 19, 2026, 4:56 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
May 2008 (Type not available)
Primary completion
Apr 2014 (Actual)
Completion
Apr 2014 (Actual)
Last update posted
Jun 12, 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 12, 2017 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00511147 live on ClinicalTrials.gov.

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