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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02335268 | Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk MDS and Thrombocytopenia | PHASE2 | COMPLETED | 77 | — | — | May 21, 2015 | Jul 1, 2021 | Aug 16, 2023 | 36 | France, Germany |
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...