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

Primary Purpose

Immune Thrombocytopenic Purpura (ITP)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura (ITP) focused on measuring Chronic idiopathic thrombocytopenic purpura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Time to achieve a platelet count > 50 x 109/L
Duration of platelet response
Duration of platelet response
Duration of platelet response
Duration of platelet response
Duration of platelet response
Duration of platelet response
Duration of platelet response
Duration of platelet response
Duration of platelet response
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Maximum Platelet Count
Number of Adverse Experiences

Full Information

First Posted
September 8, 2005
Last Updated
April 29, 2021
Sponsor
Baxalta now part of Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00162006
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2003 (Actual)
Primary Completion Date
December 3, 2003 (Actual)
Study Completion Date
December 3, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura (ITP)
Keywords
Chronic idiopathic thrombocytopenic purpura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
Primary Outcome Measure Information:
Title
Subjects Who Qualify As Treatment Responders
Description
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.
Time Frame
Baseline thru Day 15 post treatment
Secondary Outcome Measure Information:
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Screening visit
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 1 (initiation of treatment)
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 2
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 5
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 8
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 11
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 22
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 15
Title
Time to achieve a platelet count > 50 x 109/L
Time Frame
Day 29 (study termination visit)
Title
Duration of platelet response
Time Frame
Screening visit
Title
Duration of platelet response
Time Frame
Day 1 (initiation visit)
Title
Duration of platelet response
Time Frame
Day 2
Title
Duration of platelet response
Time Frame
Day 5
Title
Duration of platelet response
Time Frame
Day 8
Title
Duration of platelet response
Time Frame
Day 11
Title
Duration of platelet response
Time Frame
Day 15
Title
Duration of platelet response
Time Frame
Day 22
Title
Duration of platelet response
Time Frame
Day 29 (study termination visit)
Title
Maximum Platelet Count
Time Frame
Screening visit
Title
Maximum Platelet Count
Time Frame
Day 1 (initiation visit)
Title
Maximum Platelet Count
Time Frame
Day 2
Title
Maximum Platelet Count
Time Frame
Day 5
Title
Maximum Platelet Count
Time Frame
Day 8
Title
Maximum Platelet Count
Time Frame
Day 11
Title
Maximum Platelet Count
Time Frame
Day 15
Title
Maximum Platelet Count
Time Frame
Day 22
Title
Maximum Platelet Count
Time Frame
Day 29 (study termination visit)
Title
Number of Adverse Experiences
Time Frame
Throughout the study period of approximately 11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
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

12. IPD Sharing Statement

Learn more about this trial

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

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