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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01335035
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients 18 years of age and older
* Patients to undergo allogeneic HSCT between 6 and 18 months prior to inclusion.
* Patients with screening ANC \> 1000/mm3 and ferritin values ≥ 1000 ng/mL (ferritin values must be measured in two measurements at one-week intervals).
* Patients receiving at least 20 RBC concentrate units or 100mL/kg RBC during their lives.
* Patients giving their informed consent (prior to performing any study procedure)
Exclusion Criteria:
* Haemosiderosis not related to transfusion.
* Patients with concomitant active malignancy.
* Active known viral hepatitis or known HIV-positive.
* Mean levels of alanine aminotransferase (ALT) \> 5x ULN
* Treatment with any iron chelating agent after allogeneic HSCT.
* Uncontrolled hypertension.
Other protocol-defined inclusion/exclusion criteria may app
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01335035
Study Brief:
Protocol Section:
NCT01335035