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

Study Overview
=================
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 thrombocytopenic purpura.

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

Conditions
-----------------
Immune Thrombocytopenic Purpura (ITP)

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


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Who Qualify As Treatment Responders | Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder. | Baseline thru Day 15 post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve a platelet count > 50 x 109/L |  | Screening visit | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 1 (initiation of treatment) | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 2 | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 5 | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 8 | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 11 | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 22 | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 15 | 
| Time to achieve a platelet count > 50 x 109/L |  | Day 29 (study termination visit) | 
| Duration of platelet response |  | Screening visit | 
| Duration of platelet response |  | Day 1 (initiation visit) | 
| Duration of platelet response |  | Day 2 | 
| Duration of platelet response |  | Day 5 | 
| Duration of platelet response |  | Day 8 | 
| Duration of platelet response |  | Day 11 | 
| Duration of platelet response |  | Day 15 | 
| Duration of platelet response |  | Day 22 | 
| Duration of platelet response |  | Day 29 (study termination visit) | 
| Maximum Platelet Count |  | Screening visit | 
| Maximum Platelet Count |  | Day 1 (initiation visit) | 
| Maximum Platelet Count |  | Day 2 | 
| Maximum Platelet Count |  | Day 5 | 
| Maximum Platelet Count |  | Day 8 | 
| Maximum Platelet Count |  | Day 11 | 
| Maximum Platelet Count |  | Day 15 | 
| Maximum Platelet Count |  | Day 22 | 
| Maximum Platelet Count |  | Day 29 (study termination visit) | 
| Number of Adverse Experiences |  | Throughout the study period of approximately 11 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic idiopathic thrombocytopenic purpura