Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT02049450
Eligibility Criteria:
Inclusion Criteria:
* Patients with thalassemia on a regular and stable transfusion regimen (at least 2 RBC units within every 4-week interval for 24 weeks prior to Screening) and anticipated to receive the same transfusion regimen during the study.
* Patients with spleen enlargement at Screening, defined as spleen palpable below the costal margin and spleen volume of ≥ 450 cm3 as confirmed by MRI (or CT scan in applicable patients).
* Patients need to be on iron chelation treatment (deferoxamine or deferasirox) for at least four weeks prior to Screening
Exclusion Criteria:
* Splenectomy prior to or planned during the study
* Active serious bacterial, mycobacterial, fungal, parasitic or viral infection which requires therapy (e.g., pneumonia, tuberculosis, systemic mycosis, herpes zoster)
* Hemoglobin \<65 g/L (\<4.0 mmol/L) at Screening
* Platelet count \<75×109/L, absolute neutrophils count \< 1.5×109/L at Screening.
* Estimated MDRD \< 30 mL/min/1.73 m2 at Screening.
* ALT (SGPT) levels \>5 times ULN at Screening.
* Hepatocellular disease such as hepatitis B (presence of HBs antigen), hepatitis C (presence of HCV RNA), liver cirrhosis.
* HIV positivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02049450
Study Brief:
Protocol Section:
NCT02049450