Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura

Baxalta

Status and phase

Completed

Phase 2

Conditions

Immune Thrombocytopenic Purpura (ITP)

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00162006

160002

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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