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Also known as IGIV3I Grifols 10%, IGIV
IGIV3I Grifols · 2 trials · 2 indications
Defined by the percentage of treated patients in whom platelet counts increase from ≤ 20 x 10\^9/L to ≥ 50 x 10\^9/L by Day 8 ± 1 \[where the day of the first infusion is Day 1\]
The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10\^9/L.
| Arm | Type | Description |
|---|---|---|
| IGIV3I Grifols 10% (All Subjects) | EXPERIMENTAL | All subjects with Chronic ITP |
| 1 treatment group with IGIV3I Grifols | EXPERIMENTAL | Open label, non-randomized treatment group with IGIV3I Grifols Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses. |
| Name | Type | Description |
|---|---|---|
| IGIV3I Grifols 10% | BIOLOGICAL | IGIV3I Grifols 10% 1 g/kg/day given on two consecutive days, Day 1 and Day 2, for a total dose of 2 g/kg over two days. |
| IGIV3I Grifols | BIOLOGICAL | Immune Globulin Intravenous (Human) |
Key Inclusion Criteria: * Diagnosis of chronic ITP * Platelet count ≤ 20 x 10\^9/L * When administered corticosteroids at any time within 3 weeks before screening visit, the subject must have completed at least 3 weeks (21 days) of therapy at a stable and constant dose and schedule prior to screeni...
IGIV3I Grifols is an investigational monoclonal antibody developed by Grifols, S.A. for the treatment of immune (idiopathic) thrombocytopenic purpura, a hematologic condition in which the immune system destroys platelets. It is also known as IGIV3I Grifols 10%.
IGIV3I Grifols is being studied for immune (idiopathic) thrombocytopenic purpura, also called ITP, a bleeding disorder marked by low platelet counts. Its clinical program has focused on this hematology indication in both adult and pediatric patients.
IGIV3I Grifols is developed by Grifols, S.A., which trades under the ticker GRFS. The company is the sponsor of the clinical program evaluating the asset in immune thrombocytopenic purpura.
IGIV3I Grifols has been evaluated in Phase 3 clinical development. It is an investigational agent and has not been established as approved therapy; the Phase 3 studies in immune thrombocytopenic purpura have been completed.
Two completed Phase 3 trials have studied IGIV3I Grifols. NCT00511147 enrolled 64 patients aged 3 to 70 with chronic ITP across the United States, Canada, India, and Puerto Rico. NCT00699140 enrolled 18 adults with immune thrombocytopenic purpura in Russia, Spain, and the United Kingdom.
Yes, IGIV3I Grifols 10% is an alternative name for IGIV3I Grifols. Both names refer to the same Grifols, S.A. monoclonal antibody candidate being studied in immune (idiopathic) thrombocytopenic purpura.