Primary Outcome Measures:
- Increase of platelet count >/= 50,000/µl [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Time taken for the platelet count to reach >/= 50,000/µl [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- The length of time the platelet count remains >/= 50,000/µl [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- The maximum platelet level [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Regression of bleeding episodes during the first 10 or 14 days [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Nature, severity and frequency of adverse reactions during and after infusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
To determine if IGIV3I Grifols is a consistently effective treatment in patients diagnosed with immune thrombocytopenic purpura with respect to:
- Increase of platelet count > 50,000/µl (primary objective).
- Time taken for the platelet count to reach > 50,000/µl.
- The length of time the platelet count remains > 50,000/µl.
- The maximum platelet level.
- Regression of bleeding episodes during the first 10 or 14 days.
To determine if IGIV3I Grifols is safe with respect to:
- Nature, severity and frequency of adverse reactions during and after infusions.
- Changes in vital signs and clinically relevant changes in laboratory parameters after the infusions, including renal function (creatinine levels).
- Viral safety through the investigation of patients virology status (HAV, HBV, HCV and HIV) and assessment of alteration in their liver function.