Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura
Condition: Immune (Idiopathic) Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: IGIV3I Grifols
Intervention description: Immune Globulin Intravenous (Human)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether IGIV3I Grifols 10% is effective in the
      treatment of immune thrombocytopenic purpura.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be aged between 18 and 82 at the time of written consent.

          2. Have confirmed diagnosis of chronic ITP and fulfil all the following criteria:

               -  irrelevant history except for the symptoms of bleeding,

               -  pattern of bleedings associated with platelet disorders,

               -  physical examination irrelevant for the ITP, except for the signs of bleeding,

               -  isolated thrombocytopenia in the blood count; apart from thrombocytopenia, the
                  blood count is normal for the patient's age, or if abnormal, readily explained,

               -  peripheral blood smear consistent with ITP: thrombocytopenia with platelets of
                  normal size or slightly larger than normal, with absence of platelet clumps and
                  giant platelets; normal red blood cell and white blood cell morphology,

               -  confirmed diagnosis of immune thrombocytopenic purpura or, when any abnormal
                  finding is present, additional diagnostic evaluation excludes other causes of
                  thrombocytopenia.

               -  Previous known diagnosis of ITP for at least 3 months.

          3. To show a platelet count platelet count ≤ 20x10^9/L at the moment of the first
             infusion with the study product.

          4. Have read the patient information and consent sheet, agreed to participate in the
             trial, and signed the consent sheet.

          5. Be expected to receive treatment over 5 days and follow-up for 3 months.

          6. For women of childbearing age, use adequate contraceptive method such as oral
             contraceptives, intrauterine device or tubal ligation during one-month period after
             the first infusion in the study.

        Exclusion Criteria:

          1. Have immune thrombocytopenia secondary to other pathologies or drug mediated
             thrombocytopenia.

          2. Have a known diagnosis of other autoimmune diseases, established in the medical
             history and laboratory findings with positive results for the determination of
             antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct
             Coombs test.

          3. Present important active bleeding due to other reasons apart from the ITP.

          4. Exhibit an identifiable alternative cause of their thrombocytopenia, such as
             splenomegaly, family thrombocytopenia, bacteraemia, sepsis or active infection
             requiring or not therapy.

          5. Are presenting renal dysfunction.

          6. Have non-controlled arterial hypertension.

          7. Have documented liver cirrhosis or any hepatic disorder with alanine aminotransferase
             (ALT) levels 2.5 times or more than the normal upper limit or bilirubin greater than 2
             mg/dL.

          8. Are presenting a cardiac disease including a history of coronary artery disease,
             angina pectoris or congestive heart failure.

          9. Present known infection due to HIV or hepatitis C virus (HCV).

         10. Have been previously treated with IVIG or anti-D immunoglobulin being unresponsive.

         11. Have a history of serious adverse reactions or non-serious but frequent adverse
             reactions to intravenous immune globulin (IVIG) preparations or other products derived
             from blood.

         12. Have known allergies to any IGIV3I Grifols components, such as D-sorbitol.

         13. Are simultaneously participating in other clinical studies or have received an
             investigational drug in the 3 months prior to the start of the study.

         14. Have been involved in the present study and being treated with the formulation at 5%
             (IGIV3I Grifols 5%).

         15. Have conditions that might affect patient compliance.

         16. Are unable to provide a storage serum sample just before the first dose of IGIV3I
             Grifols.

         17. Are pregnant or nursing an infant child or unwilling to practice adequate birth
             control in 1-month period after the first infusion in the study.