Trial intelligence / Profile preview

Epoetin Alfa in Low/Int-1 Risk MDS

NCT01381809Phase 3

Key facts

Status: Completed
Start: Oct 2011
Primary completion: Jan 2015
Countries: 5
Sponsor: Janssen Pharmaceutical
Modality: Biologic, rProtein (Recombinant Protein)

Drugs: epoetin alfa
Conditions: myelodysplastic syndrome (MDS)

Overview

Phase 3, randomised, double-blind trial in myelodysplastic syndrome (MDS) comparing Epoetin alfa with Placebo (2 arms). Primary endpoint: Erythroid response at 24 weeks. Started Oct 2011; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Epoetin alfa
Epoetin alfa 450-1050 IU/kg weekly SC
Placebo
Placebo weekly SC

Who it enrols

Adult patients with IPSS Low- or Intermediate-1-Risk MDS, hemoglobin <= 10.0 g/dL, serum erythropoietin < 500 mU/mL, and low transfusion burden (<= 4 units/8 weeks). Excludes prior ESA use in last 8 weeks or prior MDS-specific therapies.

Endpoints

Primary

Erythroid response24 weeks

Secondary

Maintenance of Erythroid response48 weeks
Duration of response48 weeks
Time to first Red Blood Cell transfusion54 weeks
Transfusion-free intervals54 weeks
Number of Red Blood Cell units transfused54 weeks
Functional Assessment of Cancer Therapy-Anemia/Fatigue48 weeks
EuroQol 5-dimension questionnaire48 weeks
Drug consumption48 weeks

Results

Primary endpoints met

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