A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

Neurodegenerative Disorder

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 4

Study Identifier NCT02145026, ML29005

Condition Myelodysplastic Syndromes

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

Study 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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

Inclusion Criteria

Adult participants with low or intermediate-1 risk MDS
No previous treatment with hematopoietic growth factors within 3 months prior to screening
Symptomatic anemia (hemoglobin <10 g/dL) as determined by investigator
Serum erythropoietin <500 milliunits/milliliter (mU/mL) within 14 days prior to the first dose of study treatment
Require no red blood cell transfusion or dependent on <4 units within 8 weeks prior to screening
Clinically stable for at least 1 month prior to entry into the study
For female participants of childbearing potential and male participants with partners of childbearing potential, agreement (by participants and/or partner) to use highly effective form(s) of contraception

Exclusion Criteria

Contraindications and/or known hypersensitivity to the active substance and/or any of the excipients of epoetin beta treatment
Poorly controlled hypertension as assessed by the investigator
History of Acute Myeloid Leukemia (AML) or high risk for AML
Administration of another investigational drug within 1 month before screening or planned during the study period
Previously documented evidence of Pure Red Cell Aplasia (PRCA)

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

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A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

For the latest version of this information please go to www.forpatients.roche.com