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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

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Thrombocytopenic Purpura

Intervention: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, Principal Investigator, Affiliation: Baxter BioScience

Summary

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Institute of Haematology and Blood Transfusion, Prague 128 00, Czech Republic

University Hospital Olomouc, Olomouc 775 20, Czech Republic

University Hospital Brno, Brno 625 00, Czech Republic

University Hospital Hradec Králové, Hradec Králové 500 05, Czech Republic

Julius-Liebig Universität Giessen, Center for Internal Medicine, Department of Hematology/Oncology, Giessen 35385, Germany

Martin-Luther University Halle-Wittenberg, Klinik u. Poliklinik f. Innere Medizin IV, Hematology and Oncology, Halle/Saale 06112, Germany

University of Szeged, Second Clinic of Internal Medicine, Szeged 6720, Hungary

Markusovszky Hospital, Department of Hematology, Szombathely 9700, Hungary

University of Debrecen, Second Clinic of Internal Medicine, Debrecen 4012, Hungary

University of Szeged, Second Clinic of Internal Medicine, Szeged 6701, Hungary

Petz Aladár Teaching Hospital Györ, Györ 9002, Hungary

Medical University of Lodz, Hematology Clinic, Lodz 90-419, Poland

Additional Information

Starting date: January 2003
Ending date: December 2003
Last updated: October 18, 2006

Page last updated: June 20, 2008

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