Phase 1 Sickle Cell Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 years or older.
• People who are willing and able to provide written consent before the study begins.
• People who have a confirmed diagnosis of sickle cell disease (SCD), confirmed through specific blood tests (hemoglobin electrophoresis or liquid chromatography).
• People who are currently in a stable condition, with no hospitalisation, severe pain episode, or acute chest syndrome in the past 14 days.
• People who weigh at least 40 kg.
• People who have consistently followed their care plan and previous treatments.
• People whose SCD remains symptomatic despite at least 6 months of hydroxyurea treatment, or who have chosen not to take hydroxyurea for personal reasons — and who also meet at least one of the following: a fetal haemoglobin level below 0.5 g/dL, three or more pain episodes per year requiring strong injected pain relief, one or more acute chest syndrome episodes, or a haemoglobin level below 9 g/dL combined with a low reticulocyte count (below 250,000/mm³).

Who may not be able to join:

• People who are unable to provide informed consent.
• People who have experienced severe infection or septic shock within the past 12 weeks.
• People who have taken hydroxyurea within the past 4 weeks.
• People who are currently pregnant or breastfeeding.
• People with certain abnormal liver test results, including elevated ALT (at or above 3 times the normal upper limit), low albumin (below 2.0 mg/dL), or elevated direct bilirubin (at or above 1.5 mg/dL).
• People with significantly reduced kidney function, indicated by a serum creatinine level above 2.9 mg/dL and a creatinine clearance below 30 mL/min.
• People with a platelet count above 800 x 10⁹/L (higher than a certain threshold).
• People with a low neutrophil count (below 1.5 x 10⁹/L), a type of white blood cell important for fighting infection.
• Women of childbearing potential who are unwilling to either abstain from heterosexual intercourse or use an intrauterine device (IUD), from the screening visit until 4 weeks after the last dose of the study drug.
• Sexually active men unwilling to use a condom during any sexual contact with a woman who could become pregnant, from the screening visit until 4 weeks after the last study drug dose — this applies even to men who have had a vasectomy.
• People with significant changes in mental state or recurring seizures that require ongoing anti-seizure medication.
• People with a serious concurrent illness (such as liver, kidney, heart, or metabolic disease) where death within 24 weeks is considered likely, or people who are critically ill.
• People with a current or known diagnosis of cancer, myelodysplastic syndrome, leukaemia, or an abnormal chromosome pattern (karyotype).
• People with moderate to severe heart failure, classified as New York Heart Association (NYHA) class III or IV (confirm with trial site).
• People with an ECOG performance status score of 3 or higher, a scale used by doctors to measure how much a disease affects a person's daily abilities (confirm with trial site).
• People currently receiving ongoing blood transfusion therapy.
• People with a known history of illicit drug or alcohol misuse within the past 12 months.
• People who have taken part in another experimental drug trial within the past 28 days.
• People who have taken l-glutamine within the past 28 days.
• People who have tested positive for HIV.

Important: Always verify eligibility with the trial site directly before applying.