Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura

To determine if IGIV3I Grifols 10% is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:

• Increase of platelet count ≥ 50x10^9/L (primary objective).
• Time taken for the platelet count to reach ≥ 50x10^9/L.
• The length of time the platelet count remains ≥ 50x10^9/L.
• The maximum platelet level.
• Regression of bleeding episodes during the first 10 or 14 days.

To determine if IGIV3I Grifols 10% is safe with respect to:

Nature, severity and frequency of adverse reactions during and after infusions by percentage of subjects and percentage of infusions.

Inclusion criteria

• Be aged between 18 and 82 at the time of written consent.
• 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.
• To show a platelet count platelet count ≤ 20x10^9/L at the moment of the first infusion with the study product.
• Have read the patient information and consent sheet, agreed to participate in the trial, and signed the consent sheet.
• Be expected to receive treatment over 5 days and follow-up for 3 months.
• 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

• Have immune thrombocytopenia secondary to other pathologies or drug mediated thrombocytopenia.
• 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.
• Present important active bleeding due to other reasons apart from the ITP.
• Exhibit an identifiable alternative cause of their thrombocytopenia, such as splenomegaly, family thrombocytopenia, bacteraemia, sepsis or active infection requiring or not therapy.
• Are presenting renal dysfunction.
• Have non-controlled arterial hypertension.
• 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.
• Are presenting a cardiac disease including a history of coronary artery disease, angina pectoris or congestive heart failure.
• Present known infection due to HIV or hepatitis C virus (HCV).
• Have been previously treated with IVIG or anti-D immunoglobulin being unresponsive.
• 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.
• Have known allergies to any IGIV3I Grifols components, such as D-sorbitol.
• Are simultaneously participating in other clinical studies or have received an investigational drug in the 3 months prior to the start of the study.
• Have been involved in the present study and being treated with the formulation at 5% (IGIV3I Grifols 5%).
• Have conditions that might affect patient compliance.
• Are unable to provide a storage serum sample just before the first dose of IGIV3I Grifols.
• 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.