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IGIV Study for Chronic ITP Patients Ages 3-70

Information source: Grifols Biologicals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Thrombocytopenic Purpura

Intervention: IGIV3I Grifols 10% (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Grifols Biologicals Inc.

Official(s) and/or principal investigator(s):
Ali Khojasteh, MD, Principal Investigator, Affiliation: Capitol Comprehensive Cancer Care Clinic

Overall contact:
Paul J Pinciaro, PhD, Phone: 410-814-7617, Email: paul.pinciaro@grifols.com


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To demonstrate that IGIV3I Grifols 10% is safe and effective in raising platelet counts in patients with ITP.


Minimum age: 3 Years. Maximum age: 70 Years. Gender(s): Both.


Inclusion Criteria:

- Eligible subjects must be 3 to 70 years of age

- Must have a diagnosis of chronic ITP

- Must have a a platelet count ≤ 20 x 10(9)/L

Locations and Contacts

Paul J Pinciaro, PhD, Phone: 410-814-7617, Email: paul.pinciaro@grifols.com

Fundacion de Investigacion de Diego, San Juan 00927, Puerto Rico; Recruiting
Anmarie Ferrer, Phone: 787-722-1248, Email: aferrer@fdipr.com
Rafael D. Betancourt-Garcia, MD, Principal Investigator

University of Alberta, Edmonton, Alberta T6G 2H7, Canada; Recruiting
Juline Jabs, Phone: 780-248-1336, Email: juline.jabs@biosample.ca
Hannah Devereux, Phone: 780-248-1336, Email: hannah.devereux@biosample.ca
Bruce Rithchie, MD, Principal Investigator

Phoenix Children's Hospital, Phoenix, Arizona 85061, United States; Recruiting
Erica Olson, RN, Phone: 602-546-0171, Email: eolson1@phoenixchildrens.com
Sanjay Shah, MD, Principal Investigator

Scottsdale Medical Specialists, Scottsdale, Arizona 85258, United States; Completed

Arizona Oncology Associates, Tucson, Arizona 85745, United States; Completed

Scripps Cancer Center, LaJolla, California 92037, United States; Completed

Kenmar Research Institute, LLC, Los Angeles, California 90057, United States; Completed

Children's Hospital of Orange County, Orange, California 92868, United States; Recruiting
Brandy Gonzales, Phone: 714-532-8423, Email: bgonzales@choc.org
Diane Nugent, MD, Principal Investigator

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Robin Arens, CCRP, Phone: 860-545-9614, Email: Rarens@ccmckids.org
Nehal Parikh, MD, Principal Investigator

Cancer Center of Central Connecticut, Southington, Connecticut 06489, United States; Completed

Georgetown University, Washington, District of Columbia 20007, United States; Recruiting
Rim Abdullah, Phone: 202-687-0116, Email: ra337@georgetown.edu
Helena Jacobs, BS, Phone: 202-687-4868, Email: jacobsh@georgetown.edu
Craig Kessler, MD, Principal Investigator

VA Medical Center, Washington, District of Columbia 20422, United States; Recruiting
Mary Beth Kvanli, PA-C, Phone: 202-745-8000, Ext: 5443, Email: mary.kvanli@va.gov
Joao Ascensao, MD, Principal Investigator

Halifax Health Medical Center, Daytona Beach, Florida 32114, United States; Completed

Hematology Oncology Associates, Lake Worth, Florida 33461, United States; Completed

Lakeland Regional Cancer Center, Tampa, Florida 33607-6307, United States; Completed

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33607-6307, United States; Completed

Cleveland Clinic Florida, Weston, Florida 33331, United States; Completed

Emory University School of Medicine Winship Cancer Center, Atlanta, Georgia 30322, United States; Completed

Advocate Hope Children's Hospital, Oak Lawn, Illinois 60453, United States; Completed

University of Iowa Children's Hospital, Iowa City, Iowa 52242, United States; Completed

Children's Hospital, New Orleans, Louisiana 70118, United States; Completed

Kalamazoo Hematology & Oncology, Kalamazoo, Michigan 49048, United States; Completed

CTO Breslin Cancer Center/MSU/Great Lakes Cancer Institute, Lansing, Michigan 48910, United States; Completed

University of Mississippi, Jackson, Mississippi 39216, United States; Completed

Capital Comprehensive Cancer Care Clinic, Jefferson City, Missouri 65109, United States; Recruiting
Kara Maher, Phone: 573-893-6404, Email: research5c@socket.net
Ali Khojasteh, MD, Principal Investigator

UMDNJ-RWJ Medical School, New Brunswick, New Jersey 08901, United States; Completed

Mt. Sinai Medical Center, New York, New York 10029, United States; Completed

Children's Hospital, University of Oklahoma, Oklahoma City, Oklahoma 73104, United States; Completed

St. Joseph's Healthcare, Hamilton, Ontario L8N4A6, Canada; Completed

Western Pennsylvannia Hospital, Pittsburgh, Pennsylvania 15224, United States; Completed

Baptist Cancer Center, Beaumont, Texas 77705, United States; Completed

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Completed

Tyler Hematology Oncology PA, Tyler, Texas 75701, United States; Completed

MCV Hospital, Richmond, Virginia 23298, United States; Completed

Additional Information

Starting date: February 2008
Last updated: May 7, 2015

Page last updated: August 23, 2015

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