CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Epoetin betadrug
Likely dose
Epoetin beta 60,000 IUfrom 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/NCT02145026
NCT02145026Phase 4Completed
CompareCT.gov

A Prospective Open-Label Study of the Effectiveness of Epoetin Beta for Treating Anemic Patients With Low/Intermediate-1-Risk Myelodysplastic Syndrome (MDS)

Hoffmann-La Roche·interventional·Posted May 22, 2014·Updated Apr 24, 2020

In Brief

A Phase 4 clinical trial evaluating Epoetin beta for Myelodysplastic Syndromes. Completed, enrolled 100 participants across 10 sites.

Detailed Summary

This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult participants associated with low/intermediate-1-risk MDS. After screening, eligible participants will be treated with epoetin beta as recommended in the approved label and international guidelines for the use of epoetin in MDS participants and the dosage will be adjusted on the basis of erythroid response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 22, 2014
Enrollment StartAug 6, 2014
Primary CompletionApr 9, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 12.1 years ago

Interventions

Epoetin betadrug

Epoetin beta 30,000 or 60,000 IU per week SC injection