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Medical Standard of Care for ITP · 1 trial · 4 indications
Occurrence of a splenectomy. Participants who discontinued study during the treatment period prior to reporting a splenectomy were considered as having had a splenectomy.
Treatment failure was defined by platelet counts ≤ 20 x 10\^9/L for 4 consecutive weeks at the highest recommended dose and schedule, a major bleeding event, or change in therapy due to an intolerable side effect or bleeding symptom.
| Arm | Type | Description |
|---|---|---|
| Romiplostim | EXPERIMENTAL | Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks. |
| Standard of Care | OTHER | Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Medical Standard of Care for ITP | DRUG | - |
| Romiplostim | BIOLOGICAL | - |
Inclusion Criteria: * Subject is ≥ 18 years of age * Subject has a diagnosis of Idiopathic Thrombocytopenia Purpura (ITP) according to the American Society of Hematology (ASH) guidelines * If subject is \> 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ...
Medical Standard of Care for ITP is used for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a condition characterized by low platelet counts. It is being studied in patients with ITP and thrombocytopenia. The drug is intended to address the underlying platelet deficiency associated with this hematologic disorder.
Medical Standard of Care for ITP is developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical research on this treatment for Idiopathic Thrombocytopenic Purpura as part of its hematology portfolio.
Medical Standard of Care for ITP is in Phase 3 clinical development. It has completed one Phase 3 trial, NCT00415532, which enrolled 234 participants. The drug is investigational and has not been approved by regulatory authorities based on the available clinical trial data.
Medical Standard of Care for ITP has one completed Phase 3 clinical trial, NCT00415532, titled 'Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura.' The trial enrolled 234 adults with ITP and thrombocytopenia, was randomized and controlled, and evaluated the treatment's effects.
Medical Standard of Care for ITP is not the same as Romiplostim. In the clinical trial NCT00415532, Romiplostim (AMG 531) was compared against the medical standard of care for ITP. The standard of care represents the conventional treatment approach, while Romiplostim is a separate investigational agent being tested against it.