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

NCT ID: NCT00162006

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-13
• Study Completion Date: 2003-12-03

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.

Conditions

Immune Thrombocytopenic Purpura (ITP)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Brno, , Czechia

Hradec Králové, , Czechia

Olomouc, , Czechia

Prague, , Czechia

Giessen, , Germany

Halle, , Germany

Debrecen, , Hungary

Győr, , Hungary

Szeged, , Hungary

Szombathely, , Hungary

Lodz, , Poland

Countries

Czechia; Germany; Hungary; Poland

Other Identifiers

160002

Identifier Type: -

Identifier Source: org_study_id