Clinical trial to assess the safety and the efficacy of a new intravenous immune globulin (IGIV3I Grifols10%) in patients with idiopathic (immune) thrombocytopenic purpura.

Phase 3

Completed

Conditions: Health Condition 1: null- Chronic idiopathic (immune) thrombocytopenic purpuraHealth Condition 2: D693- Immune thrombocytopenic purpuraHealth Condition 3: D693- Immune thrombocytopenic purpura

Recruitment & Eligibility

Inclusion Criteria

1.To be male or female.

2.To be 18 to 70 years of age.

3.To have a diagnosis of chronic ITP.

4.To have a platelet count ≤ 20 x 10.e9/L.

5.To sign an informed consent form.

Exclusion Criteria

1.Has a history or clinical evidence of medical conditions (other than ITP) felt to be the underlying cause of the thrombocytopenia.

2.Has a diagnosis of secondary immune thrombocytopenia.

3.Has a history of severe (e.g. anaphylactic) reactions to blood or any blood-derived product.

4.Is suffering a serious and/or life-threatening hemorrhage/bleeding defined as:

-Any intracranial or central nervous system bleeding.

-Any hemorrhagic event in which the subject is at risk of death at the time of the event.

5.Is known to have IgA deficiency.

6.Has a documented diagnosis of thrombotic complications to polyclonal IVIG therapy in the past.

7.Is anemic (Hgb 9 g/dL).

8.Is known to have a positive test for either HIV 1/2 or HCV

9.Has a splenectomy within the prior 8 weeks to the screening visit.

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint:Response rate as defined by the proportion of treated patients in whom platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 [where the day of the first infusion is Day 1].Timepoint: From Day 1 to Day 8 ± 1;Primary efficacy endpoint:Response rate as defined by the proportion of treated patients in whom platelet counts increase from ≤ 20 x 10.e9/L to ≥ 50 x 10.e9/L by Day 8 ± 1 [where the day of the first infusion is Day 1].Timepoint: From Day 1 to Day 8 ± 1

Secondary Outcome Measures

Name	Time	Method
Time to platelet count recovery as defined by the number of days elapsed from Day 1 (the day of the first infusion of the IMP) to the day when the platelet count is first known to be 50 x 10.e9/L at any moment during the clinical follow-up period ending on Day 30 Â± 1.Timepoint: Day 1 to Day 30 Â±1 Duration of response: from Day 1 to Day 30 Â± 1 Regression of hemorrhage/bleedings: from Day 1 to Day 15 Â± 1.