Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Immunoglobulin Intravenous (Human)
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.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Immune Thrombocytopenic Purpura; Chronic Idiopathic Thrombocytopenic Purpura; Werlhofs Disease; Autoimmune Thrombocytopenia; Immunglobulin Intravenous; Chronic ITP; Platelet count; Thrombocytopenia

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.
    

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)