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Brief Title: Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
Official Title: A Phase 2/3 Trial of FG-4592 for Treatment of Anemia in Subjects With Lower Risk Myelodysplastic Syndrome
Study ID: NCT03303066
Brief Summary: The objective of this study to evaluate the efficacy FG-4592 for the treatment of anemia in Chinese participants with lower risk MDS.
Detailed Description: This is a Phase 2/3 trial with sequential Phase 2 and Phase 3 components. In each part, there is an up to 4 weeks screening period followed by a treatment period of 26 weeks and a 4 week follow-up period.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Anhui Provincial Hospital, Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
China-Japan Friendship Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University First Hospital, Beijing, Beijing, China
Peking University Third Hospital, Beijing, Beijing, China
Xiyuan Hospital, CACMS, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Lanzhou University Second Hospital, Lanzhou, Gansu, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Nan Fang Hospital, Guangzhou, Guangdong, China
Zhuzhou Central Hospital, Zhuzhou, Guangdong, China
Hainan Central Hospital, Haikou, Hainan, China
Second hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Tumor Hospital of Henan province, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of HUST, Wuhan, Hubei, China
Union Hospital Affiliated Tongji Medical College Huazhong University of Science and Technolog, Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Zhongda Hospital Southeast University, Nanjing, Jiangsu, China
The First Affiliated Hospital Of Soochow University, Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
The Affiliated Hospital of Xuzhou Medical University, Jinan, Shandong, China
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
Shanghai Tongji Hospital, Shanghai, Shanghai, China
Shaanxi Provincial People's Hospital, Xian, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University Medical College, Xian, Shanxi, China
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Blood disease hospital of Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
The Second Hospital of Tianjin Medical University, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University Medical College, Hangzhou, Zhejiang, China