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Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
This study has been completed.
First Received: September 8, 2005   Last Updated: October 18, 2006   History of Changes
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00162006
  Purpose

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Phase II

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: January 2003
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 and <= 65 years
  • ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
  • Baseline platelet count of <= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
  • No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
  • For females of child bearing potential, use of adequate birth control measures during study participation
  • Written informed consent

Exclusion Criteria:

  • Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
  • Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
  • Underlying other autoimmune or lymphoproliferative disorder
  • Uncontrolled hypertension
  • Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
  • Malignancy or history of malignancy
  • Documented selective IgA deficiency (<= 10 mg/dL)
  • Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
  • History of severe adverse reactions to blood and/or blood products
  • Pregnancy or lactation
  • Positivity for HIV, or HCV antibodies, or HBsAg
  • History of unresponsiveness to IVIG defined as a peak increment in platelet count <= 20,000/µL coincident with the last IVIG treatment course prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162006

Locations
Czech Republic
Institute of Haematology and Blood Transfusion
Prague, Czech Republic, 128 00
University Hospital Olomouc
Olomouc, Czech Republic, 775 20
University Hospital Brno
Brno, Czech Republic, 625 00
University Hospital Hradec Králové
Hradec Králové, Czech Republic, 500 05
Germany
Julius-Liebig Universität Giessen, Center for Internal Medicine, Department of Hematology/Oncology
Giessen, Germany, 35385
Martin-Luther University Halle-Wittenberg, Klinik u. Poliklinik f. Innere Medizin IV, Hematology and Oncology
Halle/Saale, Germany, 06112
Hungary
University of Szeged, Second Clinic of Internal Medicine
Szeged, Hungary, 6720
Markusovszky Hospital, Department of Hematology
Szombathely, Hungary, 9700
University of Debrecen, Second Clinic of Internal Medicine
Debrecen, Hungary, 4012
University of Szeged, Second Clinic of Internal Medicine
Szeged, Hungary, 6701
Petz Aladár Teaching Hospital Györ
Györ, Hungary, 9002
Poland
Medical University of Lodz, Hematology Clinic
Lodz, Poland, 90-419
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
  More Information

No publications provided

Study ID Numbers: 160002
Study First Received: September 8, 2005
Last Updated: October 18, 2006
ClinicalTrials.gov Identifier: NCT00162006     History of Changes
Health Authority: Czech Republic: State Institute for Drug Control;   Germany: Paul-Ehrlich-Institut;   Hungary: National Institute of Pharmacy;   Poland: Ministry of Health

Keywords provided by Baxter Healthcare Corporation:
Chronic idiopathic thrombocytopenic purpura

Study placed in the following topic categories:
Purpura
Autoimmune Diseases
Immunologic Factors
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Purpura, Thrombocytopenic
Signs and Symptoms
Thrombocytopathy
Antibodies
Thrombocytopenia
Hemorrhagic Disorders
Immunoglobulins, Intravenous
Thrombocytopenic Purpura, Autoimmune
Purpura, Thrombocytopenic, Idiopathic
Rho(D) Immune Globulin
Immunoglobulins

Additional relevant MeSH terms:
Purpura
Skin Manifestations
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Physiological Effects of Drugs
Pharmacologic Actions
Purpura, Thrombocytopenic
Signs and Symptoms
Antibodies
Thrombocytopenia
Hemorrhagic Disorders
Immunoglobulins, Intravenous
Purpura, Thrombocytopenic, Idiopathic
Rho(D) Immune Globulin
Immunoglobulins

ClinicalTrials.gov processed this record on May 06, 2009