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

An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)

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.

Study Overview

• Status: Completed
• Conditions: Immune Thrombocytopenic Purpura
• Intervention / Treatment: Biological: Immunoglobulin Intravenous (Human)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Study Site
• Italy
  • Rome, Italy
    • Study Site
• Poland
  • Bialystok, Poland
    • Study Site
  • Gdansk, Poland
    • Study Site
  • Lodz, Poland
    • Study Site
  • Poznan, Poland
    • Study Site
  • Warsaw, Poland
    • Study Site
  • Wroclaw, Poland
    • Study Site
• Russian Federation
  • Moscow, Russian Federation
    • Study Site
  • St. Petersburg, Russian Federation
    • Study Site (19)
  • St. Petersburg, Russian Federation
    • Study Site (20)
  • St. Petersburg, Russian Federation
    • Study Site (21)
• Ukraine
  • Dnipropetrovsk, Ukraine
    • Study Site
  • Kyiv, Ukraine
    • Study Site (02)
  • Kyiv, Ukraine
    • Study Site (03)
  • Lviv, Ukraine
    • Study Site
• United Kingdom
  • Taunton, United Kingdom
    • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IgPro10	Biological: Immunoglobulin Intravenous (Human); 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.; Other Names: Privigen; IgPro10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 29 days
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.	29 days
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.	29 days
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.	29 days
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.	29 days
Time to Platelet Response	Median time to reach a platelet count ≥ 50 x 10^9/L.	29 days
Duration of Platelet Response	The number of days the platelet count remained ≥ 50 x 10^9/L.	up to 29 days
Maximum Platelet Level	Maximum absolute platelet count achieved over the duration of the study.	29 days

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Othmar Zenker, MD, CSL Behring

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): November 23, 2011
• Last Update Submitted That Met QC Criteria: October 18, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Thrombocytopenia; Chronic ITP; Platelet count; Chronic Immune Thrombocytopenic Purpura; Chronic Idiopathic Thrombocytopenic Purpura; Autoimmune Thrombocytopenia; Werlhofs Disease; Immunglobulin Intravenous
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: ZLB03_003CR; 2004-000537-11 (EudraCT Number)