Clinical trial NCT00162006: Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immune Thrombocytopenic Purpura (ITP)
Keywords: Chronic idiopathic thrombocytopenic purpura
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Subjects Who Qualify As Treatment Responders
timeFrame: Baseline thru Day 15 post treatment
Secondary outcomes:
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Screening visit
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 1 (initiation of treatment)
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 2
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 5
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 8
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 11
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 22
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 15
measure: Time to achieve a platelet count > 50 x 109/L
timeFrame: Day 29 (study termination visit)
measure: Duration of platelet response
timeFrame: Screening visit
measure: Duration of platelet response
timeFrame: Day 1 (initiation visit)
measure: Duration of platelet response
timeFrame: Day 2
measure: Duration of platelet response
timeFrame: Day 5
measure: Duration of platelet response
timeFrame: Day 8
measure: Duration of platelet response
timeFrame: Day 11
measure: Duration of platelet response
timeFrame: Day 15
measure: Duration of platelet response
timeFrame: Day 22
measure: Duration of platelet response
timeFrame: Day 29 (study termination visit)
measure: Maximum Platelet Count
timeFrame: Screening visit
measure: Maximum Platelet Count
timeFrame: Day 1 (initiation visit)
measure: Maximum Platelet Count
timeFrame: Day 2
measure: Maximum Platelet Count
timeFrame: Day 5
measure: Maximum Platelet Count
timeFrame: Day 8
measure: Maximum Platelet Count
timeFrame: Day 11
measure: Maximum Platelet Count
timeFrame: Day 15
measure: Maximum Platelet Count
timeFrame: Day 22
measure: Maximum Platelet Count
timeFrame: Day 29 (study termination visit)
measure: Number of Adverse Experiences
timeFrame: Throughout the study period of approximately 11 months
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Hradec Králové
country: Czechia
city: Olomouc
country: Czechia
city: Prague
country: Czechia
city: Giessen
country: Germany
city: Halle/Saale
country: Germany
city: Debrecen
country: Hungary
city: Györ
country: Hungary
city: Szeged
country: Hungary
city: Szombathely
country: Hungary
city: Lodz
country: Poland
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: