Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Information source: Baxalta US Inc.
ClinicalTrials.gov processed this data on August 20, 2015 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: Baxalta US Inc. 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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Subjects Who Qualify As Treatment Responders
Secondary outcome: Time to achieve a platelet count > 50 x 109/Lduration of Duration of platelet response Maximum Platelet Count Safety In Terms Of Adverse Experiences
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
Brno, Czech Republic
Hradec Králové, Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
Giessen, Germany
Halle/Saale, Germany
Debrecen, Hungary
Györ, Hungary
Szeged, Hungary
Szombathely, Hungary
Lodz, Poland
Additional Information
Starting date: January 2003
Last updated: June 26, 2015
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