The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of participants with adverse events, adverse reactions, severe adverse events and severe adverse reactions as a measure of safety and tolerability during the study period.
Timeframe: Up to 52 weeks
Absolute Change in Weight (Unit: kg) From Baseline Over Time
Timeframe: Baseline, 26, 39 and 52 weeks.
Absolute Change in Height (Unit: m) From Baseline Over Time
Timeframe: Baseline, 26, 39 and 52 weeks.
Absolute Change in Temperature (Unit: ℃）From Baseline Over Time
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Blood pressure (Unit: mmHg ) From Baseline Over Time
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Heart rate (Unit: bpm) From Baseline Over Time
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Respiration (Unit: bpm) From Baseline Over Time
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Electrocardiogram (P-R (Unit: ms), QRS (Unit: ms), QTc interval (Unit: ms), etc) From Baseline Over Time
Timeframe: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Change in Auditory Function From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in White Blood Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Neutrophil Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Lymphocyte Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Monocyte Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Eosinophilic Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Basophilic Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Red Blood Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Hemoglobin (Unit: g/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Hematocrit (Unit:%) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Blood Platelet Count (Unit: 10^9/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Thrombocytocrit (Unit: %) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Alanine Aminotransferase (Unit: U/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Bilirubin (Unit:µmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Protein (Unit:g/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Albumin (Unit: g/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Globulin (Unit: g/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Alkaline Phosphatase (Unit: U/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Aspartate Aminotransferase (Unit: U/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Lactate Dehydrogenase (Unit: IU/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Urea (Unit: mmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Creatinine (Unit:µmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Glucose (Unit: mmol/L) From Baseline Over Time [ Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Potassium (Unit: mmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Sodium (Unit: mmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Chlorine (Unit: mmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Calcium (Unit: mmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Fibrinogen (Unit: g/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Prothrombin time (Unit: s) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Activated Partial Thromboplastin Time (APTT, Unit: s) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Serum Total Thyroxine (Unit: nmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Parathyroid Hormone (Unit: pg/mL) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Triiodothyronine (Unit: nmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Thyrotropin (Unit: mIU/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Urine Glucose (Unit: mmol/L) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Urine Protein (Unit: g/L)) From Baseline Over Time
Timeframe: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Testosterone (Unit: ng/ml) in men From Baseline Over Time
Timeframe: Baseline, 26, 39 and 52 weeks.
Absolute Change in Free Testosterone (Unit: nmol/L) in men From Baseline Over Time
Timeframe: Baseline, 26, 39 and 52 weeks.
Absolute Change in Follicle-generating Hormone (Unit: mIU/mL) in women From Baseline Over Time
Timeframe: Baseline, 26, 39 and 52 weeks.
Absolute Change in Luteinizing Hormon (Unit: mIU/mL) in women From Baseline Over Time
Timeframe: Baseline, 26, 39 and 52 weeks.