Status:
TERMINATED
A Study Evaluating Epoetin Alfa 40,000 IU (International Units) Every Week or 80,000 IU Every Week Compared to Placebo in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Myelodysplastic Syndromes
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that Epoetin alfa treatment reduces red blood cell transfusions in anemic patients with myelodysplastic syndromes (MDS). Myelodysplastic syndromes are a gro...
Detailed Description
This is a randomized (patients are assigned by chance to a treatment group), double-blind (neither the patient or the physician know which treatment is being received by the patient), placebo-controll...
Eligibility Criteria
Inclusion
- Diagnosis of MDS according to protocol-specified criteria via bone marrow studies performed within 12 weeks before randomization
Exclusion
- No prior or concurrent treatment with epoetin alfa or any other approved or experimental erythropoietin stimulating agents (ESAs) within the previous 12 months before randomization
- No prior use of approved or experimental agents for the treatment of MDS or recent treatment with granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) for the treatment of neutropenia
- Patients must not have secondary MDS or anemia caused by factors other than MDS (including iron deficiency, vitamin B12 or folate deficiencies, hemolysis, chronic renal failure, or gastrointestinal bleeding)
- No history (within 12 months) of deep venous thrombosis
- or history (within 6 months) of stroke, acute coronary syndrome or other arterial thrombosis
- Not currently receiving therapeutic anticoagulants or have uncontrolled hypertension
- No uncontrolled disease or dysfunction deemed clinically significant by the Investigator not attributable to MDS
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00695396
Start Date
June 1 2008
End Date
January 1 2010
Last Update
October 5 2012
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