Status:
COMPLETED
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Immune Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2003
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00162006
Start Date
January 13 2003
End Date
December 3 2003
Last Update
May 3 2021
Active Locations (11)
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1
Brno, Czechia
2
Hradec Králové, Czechia
3
Olomouc, Czechia
4
Prague, Czechia