Phase
Condition
Thalassemia
Treatment
Placebo
Luspatercept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is willing and able to adhere to the study visit schedule (for example,not scheduled to receive hematopoietic stem cell transplantation [HSCT]) and otherprotocol requirements.
Participant has documented diagnosis of β-thalassemia or Hemoglobin E/β-thalassemia (β-thalassemia with mutation and/or multiplication of alpha (α) globin is allowed).
Participant is regularly transfused, defined as: 6-25 RBC units in the 24 weeksprior to randomization and no transfusion-free period for >42 days during thatperiod.
Participant has Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Exclusion
Exclusion Criteria:
Participant has a diagnosis of Hemoglobin S/β-thalassemia or α-thalassemia (forexample, Hemoglobin H).
Participant has active hepatitis C virus (HCV) infection as demonstrated by apositive HCVribonucleic acid (RNA) test of sufficient sensitivity, or activeinfectious hepatitis B virus (HBV) as demonstrated by the presence of hepatitis Bsurface antigen (HBsAg) and/or HBVdeoxyribonucleic acid (DNA) positive, or knownpositive human immunodeficiency virus (HIV).
Participant has a history of deep venous thrombosis or stroke or thromboembolicevents (venous or arterial) requiring medical intervention ≤24 weeks prior torandomization.
Participant uses chronic anticoagulant therapy, unless the treatment stopped atleast 28 days prior to randomization. Anticoagulant therapies used for prophylaxisfor surgery or high-risk procedures as well as low-molecular-weight heparin forsuperficial venous thrombosis and chronic aspirin are allowed.
Participant who has EMH complications requiring treatment to control the growth ofEMH mass(es) during the screening period.
Participant used immunomodulatory imide drugs (IMiDs) ≤ 24 weeks prior torandomization
Study Design
Connect with a study center
Local Institution - 0002
Maoming, Guangdong 525447
ChinaSite Not Available
Local Institution - 0005
Shenzhen, Guangdong 518035
ChinaSite Not Available
Shenzhen Second People's Hospital
Shenzhen, Guangdong 518035
ChinaSite Not Available
Local Institution - 0007
Liuzhou, Guangxi 545006
ChinaSite Not Available
Local Institution - 0003
Nanning, Guangxi 530012
ChinaSite Not Available
People's Liberation Army The 923rd Hospital
Nanning, Guangxi 530012
ChinaActive - Recruiting
Hainan Medical College - First Affiliated Hospital
Haikou, Hainan 570203
ChinaActive - Recruiting
Local Institution - 0006
Haikou, Hainan 570203
ChinaSite Not Available
First People's Hospital of Yunnan Province
Kunming, Yunnan 650032
ChinaSite Not Available
Local Institution - 0010
Kunming, Yunnan 650032
ChinaSite Not Available
Local Institution - 0011
Kunming, Yunnan 650032
ChinaSite Not Available
Local Institution - 0004
Guangzhou, 510515
ChinaSite Not Available
Local Institution - 0009
Guangzhou, 510120
ChinaSite Not Available
Nanfang Hospital of Southern Medical University
Guangzhou, 510515
ChinaActive - Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, 510120
ChinaActive - Recruiting
Hainan General Hospital
Haikou, 570311
ChinaActive - Recruiting
Local Institution - 0008
Haikou, 570311
ChinaSite Not Available
Liuzhou General Hospital
Liuzhou, 545006
ChinaActive - Recruiting
Maoming People's Hospital
Maoming, 525447
ChinaActive - Recruiting
Local Institution - 0001
Nanning, 530021
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021
ChinaActive - Recruiting
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