JPRN-jRCT2080221677UnknownPhase 2
A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety of KRN321 in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome
Kyowa Hakko Kirin Co., Ltd.0 sitesStarted: December 21, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •-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
Investigators
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