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

Immune Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168038
• Other study ID #: ZLB03_003CR
• Secondary ID: 2004-000537-11
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: October 18, 2011
• Start date: December 2004
• Est. completion date: February 2006

Study information

• Verified date: October 2011
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutRussia: Pharmacological Committee, Ministry of HealthUkraine: Ministry of HealthUnited States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ministry of HealthPoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

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.

Locations

Country	Name	City	State
Germany	Study Site	Berlin
Italy	Study Site	Rome
Poland	Study Site	Bialystok
Poland	Study Site	Gdansk
Poland	Study Site	Lodz
Poland	Study Site	Poznan
Poland	Study Site	Warsaw
Poland	Study Site	Wroclaw
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
Ukraine	Study Site	Dnipropetrovsk
Ukraine	Study Site (02)	Kyiv
Ukraine	Study Site (03)	Kyiv
Ukraine	Study Site	Lviv
United Kingdom	Study Site	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

Germany,  Italy,  Poland,  Russian Federation,  Ukraine,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Time to Platelet Response	Median time to reach a platelet count = 50 x 10^9/L.	29 days	No
Secondary	Duration of Platelet Response	The number of days the platelet count remained = 50 x 10^9/L.	up to 29 days	No
Secondary	Maximum Platelet Level	Maximum absolute platelet count achieved over the duration of the study.	29 days	No

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