Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IGIV3I Grifols 10% · 1 trial · 1 indication
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 \[where the day of the first infusion is Day 1\]
| Arm | Type | Description |
|---|---|---|
| IGIV3I Grifols 10% (All Subjects) | EXPERIMENTAL | All subjects with Chronic ITP |
| 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. |
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 being developed for Immune (Idiopathic) Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura, conditions characterized by low platelet counts. It is in Phase 3 clinical development for these hematology indications.
IGIV3I Grifols is being developed by Grifols, S.A., a biopharmaceutical company traded under the ticker GRFS. The drug is currently in Phase 3 clinical trials for Immune (Idiopathic) Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura.
IGIV3I Grifols is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for the drug have been completed, with no active trials currently ongoing.
IGIV3I Grifols has completed two Phase 3 clinical trials. NCT00511147 enrolled 64 patients aged 3-70 with Idiopathic Thrombocytopenic Purpura across the United States, Canada, India, and Puerto Rico. NCT00699140 enrolled 18 patients with Immune Thrombocytopenic Purpura in Russia, Spain, and the United Kingdom.
IGIV3I Grifols is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being studied for its effects in Immune (Idiopathic) Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura, conditions involving platelet destruction.