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:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01048905
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal
* PH documented by echocardiography, defined as at TRV greater than 2.5 m/s
* Age greater than or equal to 4 years
Exclusion Criteria:
* Inability to take or tolerate oral medication
* Acute crisis or hospitalization within 1 month of enrollment
* Hepatic dysfunction (SGPT greater than 3X normal)
* Renal dysfunction (Creatinine greater than 2X normal)
* Allergy to glutamine
* Pregnancy or breastfeeding
* Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein supplements (other therapies acceptable if stable more than 3 months)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT01048905
Study Brief:
Protocol Section:
NCT01048905