Transfusion-dependent ß-thalassemia
Conditions
Interventions
Therapy group:Rottercept treatment
Sponsors
The 923rd Hospital of the Joint Logistics Support Force of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) = 18 years old; (2) Diagnosis of ß-thalassemia or hemoglobin E/ß-thalassemia, with simultaneous deletion, mutation or duplication of a-globin gene; diagnosis of a-thalassemia HbH disease (separate analysis); (3) non-transfusion-dependent, defined as = 10 units of transfused blood in the 24 weeks prior to enrollment; (4) Mean baseline Hb =10 g/dL, based on at least two measurements within 3-6 months prior to enrollment, with an interval of =1 week between each measurement, excluding Hb values within 21 days after blood transfusion; (5)ECOG PS 0-1; (6) at least 24 weeks of medication (valid data);
Exclusion criteria
Exclusion criteria: (1) Patients who have participated in any interventional clinical study of drugs or medical devices within 24 weeks; (2) Subject has a history of malignancy or current malignancy (solid tumor and hematologic malignancy), unless the subject has been disease-free (including completion of any treatment for prior malignancy) for = 5 years. However, subjects with a history of/concomitant of the following diseases: basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer of T1a or T1b (TNM clinical staging system) are permitted; (3) Patients with missing treatment data for rotercept, or more than 25% of case data missing;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and volume of blood transfusions;Serum ferritin;Number of disease-related events; | — |
Countries
China
Contacts
Public ContactYin xiaolin
The 923rd Hospital of the People's Liberation Army
Outcome results
None listed