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IGIV Study for Chronic ITP Patients Ages 3-70

Information source: Grifols Biologicals Inc.
Information obtained from ClinicalTrials.gov on December 08, 2011
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

Summary

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: Allocation: Non-Randomized, 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.

Eligibility

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

Criteria:

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

University of Alberta, Edmonton, Alberta T6G 2H7, Canada; Recruiting
Bonny Granfield, BScN, RN, Phone: 780-248-1336, Email: bgranfield@biosample.ca
Juline Skripitsky, Phone: 780-248-1336, Email: jskrip@biosample.ca

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 Fitzhenry, Phone: 714-532-8423, Email: bfitzhenry@CHOC.ORG

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

Cancer Center of Central Connecticut, Southington, Connecticut 06489, United States; Recruiting
Mark Turney, EMTP, Phone: 860-224-4408, Email: MJT2716@sbcglobal.net

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

Georgetown University, Washington, District of Columbia 20007, United States; Recruiting
Sonja K Hopper, RN, BSN, Phone: 202-687-0116, Email: skh32@georgetown.edu
Helena Jacobs, BS, Phone: 202-687-4868, Email: JacobsH@georgetown.edu

Halifax Health Medical Center, Daytona Beach, Florida 32114, United States; Recruiting
Deborah Reynolds, RN, OCN, Phone: 386-254-4213, Ext: 3913, Email: debbie.reynolds@halifax.org

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

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33607-6307, United States; Recruiting
Pamela Neu, BA, CCRP, Phone: 813-870-4387, Email: pamela.neu@baycare.org

Lakeland Regional Cancer Center, Tampa, Florida 33607-6307, United States; Recruiting
Robin Stewart, PhD, Phone: 863-904-1877, Email: robin.stewart@lrmc.com

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; Recruiting
Jane Suszek, BA, CCRP, Phone: 708-684-4384, Email: jane.suszek@advocatehealth.com

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; Recruiting
Jennifer Brewer, MA, Phone: 517-975-9532, Email: Jennifer.Brewer@hc.msu.edu
Karen Baker, RN, OCN, Phone: 517-975-9534, Email: Karen.Baker@hc.msu.edu

University of Mississippi, Jackson, Mississippi 39216, United States; Recruiting
Sarah Starnes, Phone: 601-984-2701, Email: sestarnes@ped.umsmed.edu

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

UMDNJ-RWJ Medical School, New Brunswick, New Jersey 08901, United States; Recruiting
Robin Schwartz, CCRC, MPH, Phone: 732-235-6103, Email: robschwa@umdnj.edu

Mt. Sinai Medical Center, New York, New York 10029, United States; Recruiting
Crystal Miller, RN, BSN, Phone: 212-824-7337, Ext: 57337, Email: crystal.miller@mssm.edu

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

St. Joseph's Healthcare, Hamilton, Ontario L8N4A6, Canada; Recruiting
Sandra D Messier, Phone: 905-522-1155, Ext: 35873, Email: smessier@stjoes.ca

Western Pennsylvannia Hospital, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Richard Wonder, RN, Phone: 412-578-4492, Email: rwonder@wpahs.org
Lori Stover, RN, BSN, Phone: 412-578-4392, Email: lstover@wpahs.org

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Recruiting
Jennifer Sheppard, Phone: 682-885-6791, Email: jennifer.sheppard@cookchildrens.org

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

MCV Hospital, Richmond, Virginia 23298, United States; Recruiting
Leah Nesgoda, Phone: 804-628-0399, Email: nesgodal@vcu.edu
Tammy Anderson, CCRC, CCRA, Phone: 804-827-1856, Email: tnanders@vcu.edu

Additional Information

Starting date: February 2008
Last updated: February 16, 2011

Page last updated: December 08, 2011

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