An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Epoetin Alfa; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening

• Documentation of an International Prognostic Scoring System score indicating Low- or Intermediate-1-risk disease within 12 weeks prior to screening

• Hemoglobin concentration at screening and baseline (before the first dose of study drug) of 10.0 g/dL or less

• Screening serum erythropoietin concentration of less than 500 mU/mL

• Red Blood Cell transfusion requirement of less than or equal to 4 red blood cell units over the last 8 weeks before randomization

Exclusion Criteria:

• Anemia attributed to factors other than MDS (including hemolysis, chronic renal failure, hepatitis, gastrointestinal bleeding)

• Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation therapy/exposure)

• History of malignancy, except in situ skin basal cell carcinoma or carcinoma in situ of the cervix or breast curatively treated

• Prior therapy with any erythropoiesis-stimulating agent (ESA) (including innovative ESAs and biosimilar ESAs for approved indications or for investigational use) in the last 8 weeks before randomization

• Prior use of approved or experimental agents for the treatment of MDS