Status:
UNKNOWN
Clinical Observation of Luspatercept in Treatment of Chinese Adult β-thalassaemia Patients With TD β-thalassemia
Lead Sponsor:
Hematology department of the 920th hospital
Conditions:
Effect of Drug
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assesse the efficacy and safety of luspatercept versus placebo in China patients with transfusion-dependent β-thalassaemia.
Detailed Description
This was a prospective, multicenter, open-label, multicenter clinical study to observe the efficacy and safety of luspatercept in the treatment of adult patients with transfusion-dependent β-thalassem...
Eligibility Criteria
Inclusion
- ≥18 years old;
- A clear diagnosis of transfusion-dependent β-thalassemia (including αβ mixed type) with red blood cell transfusion ≤15u within 24 weeks before enrollment (one unit of red blood cell in overseas clinical research is 200-350ml packed red blood cells, which should be converted according to Chinese clinical practice);
- Voluntarily participate in the study and sign the informed consent;
Exclusion
- pregnant or lactating women;
- Allergic to luspatercept and/or luspatercept for injection excipients;
- Severe liver dysfunction: Liver enzymes (alanine aminotransferase ALT or aspartate aminotransferase AST) ≥ 3 times normal value.;
- Severe renal injury: eGFR\<30 ml/min/1.73m3 or end-stage renal disease;
- heart disease, New York Heart Association (NYHA) class 3 or higher heart failure, or the need for treatment Severe arrhythmia, or recent myocardial infarction within 6 months;
- The patient had uncontrolled hypertension;
- Patients with a history of deep vein thrombosis or stroke within 24 weeks prior to enrollment.;
- Treatment with ESA, luspatercept, thalidomide or hydroxyurea within 12 weeks before enrollment;
- Any significant other medical condition, laboratory abnormality, or mental illness;
- Investigators deemed enrollment inappropriate.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06164821
Start Date
January 1 2024
End Date
November 30 2024
Last Update
December 22 2023
Active Locations (1)
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1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China, 650000