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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT07210450
Eligibility Criteria:
Inclusion Criteria:
* Adults (≥18 years), any sex.
* Diagnosis of non-transfusion-dependent β-thalassemia (NTDT).
* Pulmonary artery pressure (PAP) \> 35 mmHg estimated by Doppler echocardiography at screening.
* Able and willing to provide written informed consent.
* On a stable standard-of-care regimen (e.g., chelation and/or hydroxyurea) per treating physician judgment.
Exclusion Criteria:
* Age \<18 years.
* Refusal or inability to provide informed consent.
* Hepatic dysfunction: ALT \>3× upper limit of normal.
* Renal dysfunction: serum creatinine \>2× upper limit of normal.
* Known hypersensitivity to L-glutamine.
* Pregnancy or breastfeeding.
* Use of amino-acid/protein supplements within the past 3 months.
* History of other cardiac diseases associated with pulmonary hypertension (per investigator assessment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07210450
Study Brief:
Protocol Section:
NCT07210450