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Clinical Observation of Luspatercept in Treatment of Chinese Adult β-thalassaemia Patients With TD β-thalassemia

China10 participantsStarted 2024-01-01

Plain-language summary

To assesse the efficacy and safety of luspatercept versus placebo in China patients with transfusion-dependent β-thalassaemia.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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;

✕. 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;

Number of units in cumulative transfusion volume

Timeframe: Within 24 weeks

Proportion of patients with a 33% reduction in transfusion burden

Timeframe: Within 24 weeks

NCT IDNCT06164821

SponsorHematology department of the 920th hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

Chaoen Zhen, MD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥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;

✕. 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;