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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT07055503
Eligibility Criteria:
Inclusion Criteria
Subjects must satisfy the following criteria to be enrolled in the study:
1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
3. Subject has documented diagnosis of β- transfusion dependent thalassemia, defined as ect: ≥ 6 RBC units/24 weeks and no transfusion-free period for ≥ 42 days during the 24 weeks prior enrollment.
4. Transfusion history (including units or cc) for at least 6 months prior to enrollment needs to be available.
5. Subject is on chelation therapy and a fairly stable dose for at least 6 months prior to enrollment.
6. Chronic therapies (including hydroxyurea) are allowed as long as the medication dose has been stable for at least 6 months prior to enrollment.
7. Having been exposed to PRBC transfusions prepared with the Hemanext One processing system
Exclusion Criteria
The presence of any of the following will exclude a subject from enrollment:
1. Subject has currently or has a history of any significant medical condition, laboratory abnormality, or psychiatric illness.
2. Subject has had positive Coombs (antiglobulin) test anytime during the 6 months prior to enrollment.
3. Subject is scheduled to undergo or has recently (in the last 6 months) undergone splenectomy.
4. Use of luspatercept during the period of 6 months prior to enrollment and during the trial is not allowed.
5. Participation in an interventional clinical trial or use of experimental medications during the period of 6 months prior to enrollment and during the trial is not allowed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07055503
Study Brief:
Protocol Section:
NCT07055503