Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00415532 | Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura | PHASE3 | COMPLETED | 234 | — | — | Dec 1, 2006 | May 11, 2009 | Nov 8, 2022 | - | — |
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 ...