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Sponsored by: |
Bio Products Laboratory |
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Information provided by: | Bio Products Laboratory |
ClinicalTrials.gov Identifier: | NCT00504075 |
The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of a historical control. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a historical control.
Condition | Intervention | Phase |
---|---|---|
Chronic Idiopathic Thrombocytopenic Purpura |
Biological: Gammaplex, intravenous immunoglobulin Biological: Gammaplex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura |
Estimated Enrollment: | 31 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of Southern California, Keck School of Medicine, Medicine & Pathology, Division of Hematology | Recruiting |
Los Angeles, California, United States, 90089 | |
Contact: Brad Hutchinson 323-865-3978 hutchinson_b@ccnt.usc.edu | |
Contact: Nancy Berman 323-865-3879 | |
Principal Investigator: Howard Liebman, MD | |
Children's Hospital of Orange County Research Institute | Recruiting |
Orange, California, United States, 82868 | |
Contact: Laura Gates 714-515-4203 lgates@choc.org | |
Principal Investigator: Diane Nugent, MD | |
United States, District of Columbia | |
Georgetown University | Recruiting |
Washington, District of Columbia, United States, 20057 | |
Contact: Liza Vitug 202-687-0116 lmv3@georgetown.edu | |
Principal Investigator: Craig Kessler, MD | |
United States, Florida | |
Mid Florida Hematology & Oncology | Recruiting |
Orange City, Florida, United States, 32763 | |
Contact: Sandy Davis 386-566-3303 swarrington@auafl.com | |
Principal Investigator: Gregory Ortega, MD | |
United States, Maryland | |
Center for Cancer & Blood Disorders | Recruiting |
Bethesda, Maryland, United States, 20817 | |
Contact: Natalie Bongiorno, RN, MSHS 301-571-2016 nbongiorno@ccbdmd.com | |
Principal Investigator: Victor Priego, MD | |
United States, New York | |
New York Hospital / Cornell University, Division of Pediatrics | Recruiting |
New York, New York, United States, 10021 | |
Contact: Jared Levan 212-746-3423 jal2029@med.cornell.edu | |
Principal Investigator: James B Bussel, MD | |
Department of Pediatrics, SUNY at Stony Brook | Recruiting |
Stony Brook, New York, United States, 11794-8111 | |
Contact: Carol Martin 631-638-0838 caamartin@notes.cc.sunysb.edu | |
Principal Investigator: Robert Parker, MD | |
United States, Ohio | |
Case Western Reserve University School of Medicine, Hematology-Oncology, WRB 2-132 | Recruiting |
Cleveland, Ohio, United States, 44106-7284 | |
Contact: Bonnie Rosolowski, RRT, CCRC bonnie.rosolowski@uhhospitals.org | |
Principal Investigator: Keith McCrae, MD | |
United States, Oregon | |
Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Jenifer Borruel Rector, RN BSN CCRC 503-494-7187 borruelr@ohsu.edu | |
Principal Investigator: Lynn Boshkov, MD | |
United States, Texas | |
Cancer Care Centers of South Texas | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Joanne Hardy, RN 210-595-5683 joanne.hardy@usoncology.com | |
Principal Investigator: Roger M Lyons, MD |
Principal Investigator: | Melvin Berger, MD | Rainbow Babies and Children's Hospital, Cleveland, OH 44106 |
Responsible Party: | Rainbow Babies & Children's Hospital, Cleveland, Ohio ( Melvin Berger, MD, Principal Investigator ) |
Study ID Numbers: | GMX02 |
Study First Received: | July 18, 2007 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00504075 |
Health Authority: | United States: Food and Drug Administration |
Idiopathic Thrombocytopenic Purpura Bleeding disorders Immune System and Disorders |
Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemorrhage Hemostatic Disorders Purpura, Thrombocytopenic Thrombocytopathy |
Signs and Symptoms Antibodies Thrombocytopenia Hemorrhagic Disorders Immunoglobulins, Intravenous Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic Rho(D) Immune Globulin Immunoglobulins |
Skin Manifestations Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |