Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
Anemia, Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Anemia focused on measuring Myelodysplastic Syndromes, Anemia, Hemoglobin (Hb), Low Risk Myelodysplastic Syndrome
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts (documented within 12 weeks prior to Day 1)
- Screening Hb <10 g/dL and ≥6g/dL
- Transfusion independent defined as no red blood cell transfusions within 12 weeks of Day 1
- ESA-naïve (less than 4 weeks of ESA treatment in total, and not within 30 days of Day 1)
- ECOG of 0-2 at screen
Key Exclusion Criteria:
- Diagnosis of secondary MDS
- Significant myelofibrosis (>2+fibrosis)
- Any prior therapy with antithymocyte globulin, azacitidine, or decitabine. Or Prior therapy with cyclosporine, thalidomide , or lenalidomide within 12 weeks prior to Day 1
- Baseline erythropoietin level of >400 mIU/mL
- Clinically significant anemia due to non-MDS etiologies
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- Anhui Provincial Hospital
- The First Affiliated Hospital of Anhui Medical University
- China-Japan Friendship Hospital
- Peking Union Medical College Hospital
- Peking University First Hospital
- Peking University Third Hospital
- Xiyuan Hospital, CACMS
- Fujian Medical University Union Hospital
- Lanzhou University Second Hospital
- Guangdong General Hospital
- Nan Fang Hospital
- Zhuzhou Central Hospital
- Hainan Central Hospital
- Second hospital of Hebei Medical University
- Tumor Hospital of Henan province
- Tongji Hospital, Tongji Medical College of HUST
- Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog
- The Third Xiangya Hospital of Central South University
- Jiangsu Province Hospital
- Zhongda Hospital Southeast University
- The First Affiliated Hospital Of Soochow University
- Northern Jiangsu People's Hospital
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine
- Qilu Hospital of Shandong University
- The Affiliated Hospital of Xuzhou Medical University
- Huashan Hospital Affiliated to Fudan University
- Shanghai Sixth People's Hospital
- Shanghai Tongji Hospital
- Shaanxi Provincial People's Hospital
- The First Affiliated Hospital of Xi'an Jiao Tong University Medical College
- Sichuan Provincial People's Hospital
- West China Hospital, Sichuan University
- Blood disease hospital of Chinese Academy of Medical Sciences
- The Second Hospital of Tianjin Medical University
- Tianjin Medical University General Hospital
- First Affiliated Hospital of Kunming Medical University
- The First Affiliated Hospital, Zhejiang University Medical College
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Phase 2 Part: FG-4592
Phase 3 Part: FG-4592
Phase 3 Part: Placebo
Fixed starting doses (different doses for lower body weight & higher body weight) of FG-4592 administered orally 3 times a week (TIW) for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.
Fixed starting doses (different doses for lower body weight & higher body weight) of FG-4592 administered orally TIW for up to 26 weeks; dose adjustments to Hb levels are allowed during the study.
Placebo (matching to FG-4592) administered orally TIW for up to 26 weeks.