A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
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This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
Serum EPO concentration ≤ 500 mIU/mL
Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations
Previous bone marrow or hematopoietic stem cell transplantation
History of pure red cell aplasia
Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
Those who have increased risk of thrombosis during the study
Uncontrolled diabetes mellitus
Concurrent active infection or chronic inflammatory disease
Other causes of anemia
Previous or concurrent active malignancies other than MDS