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

Immune Thrombocytopenic Purpura (ITP) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162006
• Other study ID #: 160002
• Status: Completed
• Phase: Phase 2
• Start date: January 13, 2003
• Est. completion date: December 3, 2003

Study information

• Verified date: April 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 3, 2003
• Est. primary completion date: December 3, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura (ITP)
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Countries where clinical trial is conducted

Czechia,  Germany,  Hungary,  Poland, 

Outcome

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