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

Phase 3

Completed

• Conditions: Immune Thrombocytopenic Purpura
• Interventions: Biological: Immunoglobulin Intravenous (Human)

• Registration Number: NCT00168038
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Study Completion: 2006-02
• Results First Submitted: 2011-08-22
• Status Verified: 2011-10
• Results First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Results First Posted: 2011-11-23
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IgPro10	Immunoglobulin Intravenous (Human)	-

Primary Outcome Measures

Name	Time	Method
Platelet Response	7 days	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

Name	Time	Method
Regression of Hemorrhage (Skin)	up to 29 days	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)	29 days	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)	29 days	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)	29 days	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)	29 days	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	29 days	Median time to reach a platelet count ≥ 50 x 10\^9/L.
Duration of Platelet Response	up to 29 days	The number of days the platelet count remained ≥ 50 x 10\^9/L.
Maximum Platelet Level	29 days	Maximum absolute platelet count achieved over the duration of the study.

Trial Locations

Locations (6)

Study Site (21); 🇷🇺 St. Petersburg, Russian Federation

Study Site (02); 🇺🇦 Kyiv, Ukraine

Study Site (03); 🇺🇦 Kyiv, Ukraine

Study Site; 🇬🇧 Taunton, United Kingdom

Study Site (20); 🇷🇺 St. Petersburg, Russian Federation

Study Site (19); 🇷🇺 St. Petersburg, Russian Federation