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

• ClinicalTrials.gov Identifier: NCT00168038
• Recruitment Status: Completed
• First Posted: September 14, 2005
• Results First Posted: November 23, 2011
• Last Update Posted: November 23, 2011
• Sponsor: CSL Behring
• Information provided by (Responsible Party): CSL Behring

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.

Condition or disease	Intervention/treatment	Phase
Immune Thrombocytopenic Purpura	Biological: Immunoglobulin Intravenous (Human)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multicenter Study on the Efficacy and Safety of IgPro10 in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
• Study Start Date: December 2004
• Actual Study Completion Date: February 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Platelet Response [ Time Frame: 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 :

1. Regression of Hemorrhage (Skin) [ Time Frame: 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.
2. Regression of Hemorrhage (Oral Cavity) [ Time Frame: 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.
3. Regression of Hemorrhage (Genitourinary Tract) [ Time Frame: 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.
4. Regression of Hemorrhage (Nose) [ Time Frame: 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.
5. Regression of Hemorrhage (Internal) [ Time Frame: 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.
6. Time to Platelet Response [ Time Frame: 29 days ]
   Median time to reach a platelet count ≥ 50 x 10^9/L.
7. Duration of Platelet Response [ Time Frame: up to 29 days ]
   The number of days the platelet count remained ≥ 50 x 10^9/L.
8. Maximum Platelet Level [ Time Frame: 29 days ]
   Maximum absolute platelet count achieved over the duration of the study.

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Germany

Study Site

Berlin, Germany

Italy

Study Site

Rome, Italy

Poland

Study Site

Bialystok, Poland

Study Site

Gdansk, Poland

Study Site

Lodz, Poland

Study Site

Poznan, Poland

Study Site

Warsaw, Poland

Study Site

Wroclaw, Poland

Russian Federation

Study Site

Moscow, Russian Federation

Study Site (19)

St. Petersburg, Russian Federation

Study Site (20)

St. Petersburg, Russian Federation

Study Site (21)

St. Petersburg, Russian Federation

Ukraine

Study Site

Dnipropetrovsk, Ukraine

Study Site (02)

Kyiv, Ukraine

Study Site (03)

Kyiv, Ukraine

Study Site

Lviv, Ukraine

United Kingdom

Study Site

Taunton, United Kingdom

Sponsors and Collaborators

CSL Behring

Investigators

• Study Director: Othmar Zenker, MD; CSL Behring

More Information

Publications of Results:

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.

• Responsible Party: CSL Behring
• ClinicalTrials.gov Identifier: NCT00168038
• Other Study ID Numbers: ZLB03_003CR; 2004-000537-11 ( EudraCT Number )
• First Posted: September 14, 2005
• Results First Posted: November 23, 2011
• Last Update Posted: November 23, 2011
• Last Verified: October 2011

Keywords provided by CSL Behring:

Chronic Immune Thrombocytopenic Purpura; Chronic Idiopathic Thrombocytopenic Purpura; Werlhofs Disease; Autoimmune Thrombocytopenia; Immunglobulin Intravenous; Chronic ITP; Platelet count; Thrombocytopenia

Additional relevant MeSH terms:

Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Blood Coagulation Disorders; Hematologic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Immune System Diseases; Hemorrhagic Disorders; Autoimmune Diseases; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunologic Factors; Physiological Effects of Drugs