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Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10

Primary Purpose

Immune Thrombocytopenic Purpura

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Immunoglobulin Intravenous (Human)
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura focused on measuring Chronic Immune Thrombocytopenic Purpura, Chronic Idiopathic Thrombocytopenic Purpura, Werlhofs Disease, Autoimmune Thrombocytopenia, Immunglobulin Intravenous, Chronic ITP, Platelet count, Thrombocytopenia

Eligibility Criteria

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

Key Inclusion Criteria: Diagnosis of chronic ITP defined by: Failure to find other causes of thrombocytopenia; Platelet count ≤ 150 x 10^9/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months Platelet counts ≤ 20 x 10^9/L Key Exclusion Criteria: Planned splenectomy throughout the study period Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening Treatment with intravenous steroids within 10 days prior to screening Change of oral steroid treatment within 15 days prior to screening Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy Abnormal results in the following laboratory parameters: Hemoglobin < 10 g/dL; Total bilirubin > 1.5 x upper normal limit; ALAT > 2.5 x upper normal limit; ASAT > 2.5 x upper normal limit; Creatinine > 1.5 x upper normal limit; Urea > 1.5 x upper normal limit Positive direct Coombs test Patients with one of the following concomitant diseases Clinical active SLE Known or suspected HIV infection Acute hepatitis Clinically active chronic hepatitis Lymphoproliferative disease Heart failure Grade III or IV according to the New York Heart Association classification Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)

Sites / Locations

  • Study Site
  • Study Site
  • Study Site
  • Study Site
  • Study Site
  • Study Site
  • Study Site
  • Study Site
  • Study Site
  • Study Site (19)
  • Study Site (20)
  • Study Site (21)
  • Study Site
  • Study Site (02)
  • Study Site (03)
  • Study Site
  • Study Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IgPro10

Arm Description

Outcomes

Primary Outcome Measures

Platelet Response
The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.

Secondary Outcome Measures

Regression of Hemorrhage (Skin)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Regression of Hemorrhage (Oral Cavity)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Regression of Hemorrhage (Genitourinary Tract)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Regression of Hemorrhage (Nose)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Regression of Hemorrhage (Internal)
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Time to Platelet Response
Median time to reach a platelet count ≥ 50 x 10^9/L.
Duration of Platelet Response
The number of days the platelet count remained ≥ 50 x 10^9/L.
Maximum Platelet Level
Maximum absolute platelet count achieved over the duration of the study.

Full Information

First Posted
September 12, 2005
Last Updated
October 18, 2011
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00168038
Brief Title
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
Official Title
An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of IgPro10 in the treatment of patients with chronic immune thrombocytopenic purpura (ITP). The main efficacy parameter is the proportion of patients responding to treatment by an increase of platelet count to ≥ 50 x 10^9/L.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura
Keywords
Chronic Immune Thrombocytopenic Purpura, Chronic Idiopathic Thrombocytopenic Purpura, Werlhofs Disease, Autoimmune Thrombocytopenia, Immunglobulin Intravenous, Chronic ITP, Platelet count, Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgPro10
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Immunoglobulin Intravenous (Human)
Other Intervention Name(s)
Privigen, IgPro10
Intervention Description
A dose of 1 g IgG per kg body weight (bw) administered on two consecutive days resulting in the total treatment dosage of 2 g IgG per kg bw.
Primary Outcome Measure Information:
Title
Platelet Response
Description
The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 50 x 10^9/L within the specified time frame.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Regression of Hemorrhage (Skin)
Description
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Time Frame
up to 29 days
Title
Regression of Hemorrhage (Oral Cavity)
Description
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Time Frame
29 days
Title
Regression of Hemorrhage (Genitourinary Tract)
Description
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Time Frame
29 days
Title
Regression of Hemorrhage (Nose)
Description
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Time Frame
29 days
Title
Regression of Hemorrhage (Internal)
Description
Number of subjects with a decrease in the severity of bleeding from baseline (prior to first infusion) on at least one post-infusion assessment during the study period (e.g., a change from moderate to mild or a change from mild to none). Regression of hemorrhages was tabulated separately for the organ systems skin, oral cavity, genitourinary tract, nose, and internal.
Time Frame
29 days
Title
Time to Platelet Response
Description
Median time to reach a platelet count ≥ 50 x 10^9/L.
Time Frame
29 days
Title
Duration of Platelet Response
Description
The number of days the platelet count remained ≥ 50 x 10^9/L.
Time Frame
up to 29 days
Title
Maximum Platelet Level
Description
Maximum absolute platelet count achieved over the duration of the study.
Time Frame
29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of chronic ITP defined by: Failure to find other causes of thrombocytopenia; Platelet count ≤ 150 x 10^9/L over 6 months or response to a previous treatment with subsequent decrease in platelet count even if duration of chronic ITP is less than 6 months Platelet counts ≤ 20 x 10^9/L Key Exclusion Criteria: Planned splenectomy throughout the study period Treatment with IVIG or anti-D immunoglobulin within 3 weeks prior to screening Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening Treatment with intravenous steroids within 10 days prior to screening Change of oral steroid treatment within 15 days prior to screening Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy Abnormal results in the following laboratory parameters: Hemoglobin < 10 g/dL; Total bilirubin > 1.5 x upper normal limit; ALAT > 2.5 x upper normal limit; ASAT > 2.5 x upper normal limit; Creatinine > 1.5 x upper normal limit; Urea > 1.5 x upper normal limit Positive direct Coombs test Patients with one of the following concomitant diseases Clinical active SLE Known or suspected HIV infection Acute hepatitis Clinically active chronic hepatitis Lymphoproliferative disease Heart failure Grade III or IV according to the New York Heart Association classification Any other concomitant disease that has influence on the clotting system (i.e. hemophilia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Othmar Zenker, MD
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Study Site
City
Berlin
Country
Germany
Facility Name
Study Site
City
Rome
Country
Italy
Facility Name
Study Site
City
Bialystok
Country
Poland
Facility Name
Study Site
City
Gdansk
Country
Poland
Facility Name
Study Site
City
Lodz
Country
Poland
Facility Name
Study Site
City
Poznan
Country
Poland
Facility Name
Study Site
City
Warsaw
Country
Poland
Facility Name
Study Site
City
Wroclaw
Country
Poland
Facility Name
Study Site
City
Moscow
Country
Russian Federation
Facility Name
Study Site (19)
City
St. Petersburg
Country
Russian Federation
Facility Name
Study Site (20)
City
St. Petersburg
Country
Russian Federation
Facility Name
Study Site (21)
City
St. Petersburg
Country
Russian Federation
Facility Name
Study Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Study Site (02)
City
Kyiv
Country
Ukraine
Facility Name
Study Site (03)
City
Kyiv
Country
Ukraine
Facility Name
Study Site
City
Lviv
Country
Ukraine
Facility Name
Study Site
City
Taunton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19635187
Citation
Robak T, Salama A, Kovaleva L, Vyhovska Y, Davies SV, Mazzucconi MG, Zenker O, Kiessling P; International Privigen in ITP Study Group. Efficacy and safety of Privigen, a novel liquid intravenous immunoglobulin formulation, in adolescent and adult patients with chronic immune thrombocytopenic purpura. Hematology. 2009 Aug;14(4):227-36. doi: 10.1179/102453309X439773.
Results Reference
result
Links:
URL
http://www.cslbehring.com/clinical-trials/contact-us.htm?registryRefNum=NCT00168038&registryName=ctgov
Description
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Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10

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