CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
N-Plate / romiplostimdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02335268
NCT02335268Phase 2Completed
CompareCT.gov

Prospective Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) and Thrombocytopenia - the EUROPE-trial

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH·interventional·Posted Jan 9, 2015·Updated Aug 16, 2023

In Brief

A Phase 2 clinical trial evaluating N-Plate / romiplostim for Myelodysplastic Syndromes. Completed, enrolled 77 participants across 36 sites in 2 countries.

Detailed Summary

There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesFrance, Germany
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 9, 2015
Enrollment StartMay 21, 2015
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 11.5 years ago

Interventions

N-Plate / romiplostimdrug

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