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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT00162006
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Baxalta now part of Shire
• Public title: Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
• Scientific 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
• Date of first enrolment: January 13, 2003
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00162006
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Czech Republic, Czechia, Germany, Hungary, Poland

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenic Purpura (ITP)

Intervention(s)

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

Primary Outcome(s)

Subjects Who Qualify As Treatment Responders [Time Frame: Baseline thru Day 15 post treatment]

Secondary Outcome(s)

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 1 (initiation of treatment)]

Duration of platelet response [Time Frame: Screening visit]

Number of Adverse Experiences [Time Frame: Throughout the study period of approximately 11 months]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 2]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 5]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Screening visit]

Duration of platelet response [Time Frame: Day 1 (initiation visit)]

Duration of platelet response [Time Frame: Day 15]

Duration of platelet response [Time Frame: Day 2]

Duration of platelet response [Time Frame: Day 22]

Duration of platelet response [Time Frame: Day 8]

Duration of platelet response [Time Frame: Day 29 (study termination visit)]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 15]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 22]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 8]

Duration of platelet response [Time Frame: Day 11]

Duration of platelet response [Time Frame: Day 5]

Maximum Platelet Count [Time Frame: Day 11]

Maximum Platelet Count [Time Frame: Day 29 (study termination visit)]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 29 (study termination visit)]

Maximum Platelet Count [Time Frame: Day 1 (initiation visit)]

Maximum Platelet Count [Time Frame: Day 22]

Maximum Platelet Count [Time Frame: Screening visit]

Maximum Platelet Count [Time Frame: Day 15]

Maximum Platelet Count [Time Frame: Day 2]

Maximum Platelet Count [Time Frame: Day 5]

Maximum Platelet Count [Time Frame: Day 8]

Time to achieve a platelet count > 50 x 109/L [Time Frame: Day 11]

Secondary ID(s)

160002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors