Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
N-Plate/ romiplostim · 1 trial · 1 indication
The primary efficacy endpoint was the rate of HI-P defined as an absolute increase of platelet count to ≥ 30/nL for patients starting at \> 20/nL or an increase of platelets from \< 20/nL to \> 20/nL and by at least 100%, according to IWG 2006 criteria lasting for ≥ 8 weeks after at least 16 Weeks of romiplostim treatment.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Stratification into group 1 if Score (Baseline-TPO Level and previous thrombocyte transfusions) are +3 TPO based model to predict subsequent response to romiplostim in MDS patients with IPSS Low/Int-1 according to a model developed by Sekeres et. al./ BJH 2014 |
| Group 2 | EXPERIMENTAL | Stratification into group 2 if Score (Baseline-TPO Level and previous thrombocyte transfusions) are -1 or -2 TPO based model to predict subsequent response to romiplostim in MDS patients with IPSS Low/Int-1 according to a model developed by Sekeres et. al./ BJH 2014 |
| Group 3 | EXPERIMENTAL | Stratification into group 3 if Score (Baseline-TPO Level and previous thrombocyte transfusions) are -6 TPO based model to predict subsequent response to romiplostim in MDS patients with IPSS Low/Int-1 according to a model developed by Sekeres et. al./ BJH 2014 |
| Name | Type | Description |
|---|---|---|
| N-Plate / romiplostim | DRUG | medical intervention in 3 patient groups (MDS patients with IPSS Low/Int-1) that are stratified according to their baseline TPO-Level and previous transfusions |
Inclusion Criteria: * Subjects must meet the following inclusion/exclusion criteria to be eligible for the study. * Must understand and voluntarily sign the informed consent form * Age older 18 years at the time of signing the informed consent form * Must be able to adhere to the study visit schedu...
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N-Plate, also known as romiplostim, is being studied in myelodysplastic syndromes, specifically in patients with IPSS low or intermediate-1 risk MDS who have thrombocytopenia. It is an investigational use in this setting, evaluated in a Phase 2 trial rather than an approved MDS indication.
N-Plate, or romiplostim, is developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the company behind the romiplostim program, including the Phase 2 study conducted in patients with lower-risk myelodysplastic syndromes and thrombocytopenia.
Romiplostim is in Phase 2 development for myelodysplastic syndromes. The relevant study, NCT02335268, was a Phase 2 trial that has been completed, and it enrolled 77 patients. This MDS program is separate from any approved uses of the product.
The trial is NCT02335268, titled Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia. It was a completed Phase 2 study with 77 enrolled patients, run in France and Germany, and it enrolled adults aged 18 years and older.
Yes. N-Plate and romiplostim refer to the same product, with N-Plate being the brand name and romiplostim the generic or nonproprietary name. Both names appear in the Phase 2 myelodysplastic syndromes study NCT02335268, so searches for either term point to the same asset.
Romiplostim is investigational for myelodysplastic syndromes and remains in clinical development for that indication, with the Phase 2 study NCT02335268 completed. The trial enrolled 77 patients with IPSS low or intermediate-1 risk MDS and thrombocytopenia, and it was a controlled study without randomization or double blinding.