thalassemia
Conditions
Interventions
2.5 mg/kg:dosage 2.5mg/kg
5 mg/kg:dosage 2.5mg/kg
10 mg/kg:dosage 10mg/kg
20 mg/kg:dosage 20mg/kg
30 mg/kg:dosage 30mg/kg
45mg/kg:dosage 45mg/kg
60mg/kg:dosage 60mg/kg
Low dose:low dosage
Medium dose:Medium dose
High dose:High dose
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) The thalassemia patients Serum ferritin of> 1000 ug/L; 2) Aged older than 16(including 16); 3) No blood transfusion within 2 weeks before enrollment and hemoglobin of =80 g/L; 4) volunteer for the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Hematology screening for HIV antibodies or HBV surface antigen or HCV antibody or TP antibody positive, or hepatitis B core antibody (HbcAb) and HBV-DNA positive; 2) Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation,gastrointestinal surgery, and other potential intestinal complications considered by researchers; 3) Patients with abnormal liver function (ALT /AST> 2.5 × ULN) or those with abnormal renal function (serum creatinine> 1.5 × ULN); 4) Active infection uncontrolled; 5) The patients who are currently taking CYP3A strong inducer or strong inhibitor drugs or the drug may extend the QT interval , but can not temporarily interrupt the use of such drugs, and can not use other drugs to replace; 6) Allergic constitution: Allergy or contraindications to the main ingredients or excipients of CN128 tablets (microcrystalline cellulose, croscarmellose sodium, silica, sodium stearyl fumarate, Opadry); 7) ECG abnormalities have clinical significance: congenital long QT syndrome or known family history of long QT syndrome; QTc> 450 ms (male) or QTc> 470 ms (female); clinically significant ventricular or atrial Fast arrhythmia; 8) Birth planner (including male subjects) within or within 3 months after the end of the trial; 9) Blood donation in the last 3 month. 10) Have a history of addictions (more than 5 cigarettes / day or use a considerable amount of nicotine products), alcoholism history (more than 14 alcohol consumption per week: 1 alcohol unit equal to 10mL or 8g pure alcohol, 25mL 40% white wine, 330mL 5 % Beer, 175mL 12% of the wine, respectively, about 1.0,1.5,2.0 alcohol units), drug abuse history, history of drug abuse; 11) Smoking within 48 hours before applying the drug or using any food or drink (including chocolate, tea, coffee or cola drinks, etc.) containing alcohol, xanthine or grapefruit; 12) Participated in other clinical trials in the three months before taking the test preparation, except for non-interventional studies; 13) Nicotine, urine screening results were positive; 14) Blood collection difficulties; 15) Unsuitable to participate in the trial considered by the researchers (such as Poor health, poor compliance, unwillingness or inability to comply with treatment plan, including failure to visit on time).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;AUC0-t;AUC0-inf;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactShentu Jianzhong
the First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed