ß-thalassemia Major
Conditions
Interventions
Group One:Hydroxyurea
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as ß-thalassemia major by genotype and clinic manifestation; 2. Patients aged between 3 and 12 years old; 3. Patients who are transfusion independent to maintain a hemoglobin level above 60g/L prior to this clinical trial; 4. Informed consent should be signed before the start of this clinical trial. 5. Patients expected survival time (EST) is greater than 3 months; 6. Laboratory indicators : liver and kidney function in line with conventional clinical trial standards.
Exclusion criteria
Exclusion criteria: 1. Patients who received EPO, yisuishengxue granule, hydroxyurea, thalidomide, decitabine, azacytidine and butyrate drugs within the first three months. 2. Patients with severe cardiopulmonary renal insufficiency; 3. Patients with heart failure and liver damage; 4. Patients with severe diseases such as cardiovascular and cerebrovascular diseases and tumors; 5. Patients with history of arteriovenous thrombosis 3 months prior to this clinical study; 6. Patients with anemia due to other causes; 7. Patients with mental disease; 8. Patients who cannot take oral drugs; 9. Pregnancy, breast feeding, or patients in reproductive ages without any measurements of contraception; 10. Patients who are allergy to hydroxyurea; 11. Patients take part in other kinds of clinical trials; 12. Other conditions that investigators consider to not be suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine;hemoglobin A;hemoglobin F;Blood transfusion frequency;Blood transfusion volume; | — |
Countries
China
Contacts
Public ContactZeng Fanyi
Shanghai Children's Hospital
Outcome results
None listed