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 (romiplostim) is used for Myelodysplastic Syndromes (MDS), specifically in patients with IPSS low or intermediate-1 risk MDS and thrombocytopenia. It is being developed by Amgen Inc. (AMGN) and is currently in Phase 2 clinical development as an investigational therapy.
N-Plate (romiplostim) is a small molecule developed by Amgen Inc. (AMGN) for the treatment of Myelodysplastic Syndromes. The specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here.
N-Plate (romiplostim) is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is being investigated for use in Myelodysplastic Syndromes and is currently in Phase 2 clinical trials.
N-Plate (romiplostim) is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing development focuses on Myelodysplastic Syndromes, with a completed Phase 2 trial that enrolled 77 participants.
N-Plate (romiplostim) has one completed Phase 2 trial, NCT02335268, titled "Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia." The trial enrolled 77 participants in France and Germany and was a controlled, biomarker-selected study.
Yes, N-Plate (romiplostim) is the same as romiplostim. The drug is known by both names, with romiplostim being the generic name and N-Plate a brand name. It is being developed by Amgen Inc. (AMGN) for Myelodysplastic Syndromes.