Phase 1 Sickle Cell Disease Trial, Recruiting

Written by an AI model from the 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 who have signed a written consent form before any study procedures begin.
• People aged between 18 and 65 years old.
• People with a confirmed diagnosis of sickle cell disease (specifically the HbSS or HbSBeta^0 type), confirmed by a blood test — and if the person has had a blood transfusion in the past, the diagnosis must have been confirmed at least 60 days after that transfusion.
• People who have not had a blood transfusion in the 60 days before signing consent, or whose blood test shows no sign of donor blood (Hb A) remaining in their system.
• People whose liver, blood cell, and organ function meet specific levels as measured by blood tests (confirm details with the trial site).
• People who are taking hydroxyurea must have been on a stable dose for at least 3 months before signing consent.
• Women who could become pregnant must have a negative pregnancy test during the screening period.
• Women who could become pregnant, as well as men whose partners could become pregnant, must either abstain from sex as part of their usual lifestyle, or agree to use 2 effective forms of contraception from the time of signing consent, throughout the study, and for 28 days after the last dose of the study treatment.
• People who are willing to follow all study procedures for the full duration of the trial.

Who may not be able to join:

• People who have had a severe pain crisis requiring intravenous or injected pain treatment within 14 days of signing consent.
• People with a history of low white blood cell counts (neutropenia), unless it is a known benign ethnic variation, caused by hydroxyurea, or a cyclical pattern (confirm with trial site).
• People with a history of a brain condition called posterior reversible encephalopathy syndrome (PRES) (confirm with trial site).
• People with poorly controlled high blood pressure, unless it has been well controlled for more than 90 days before joining.
• People with an active hepatitis B or C infection (those with hepatitis C may be able to rescreen after receiving appropriate treatment).
• People with a history of liver inflammation caused by medication (drug-induced cholestatic hepatitis).
• People with a history of any cancer.
• People who have HIV with signs of active infection that is not well managed (confirm with trial site).
• People with a current or recent psychiatric condition that, in the opinion of the study doctor, could affect their ability to take part in study visits and procedures.
• People who are currently enrolled in another clinical trial involving an experimental or marketed treatment.
• People currently using or who have used certain newer sickle cell disease treatments — specifically L-glutamine, voxelotor, or crizanlizumab — within 7 days of signing consent.
• People who have previously had a bone marrow or stem cell transplant.
• People who are currently pregnant or breastfeeding.
• People currently taking certain medications that strongly interact with a liver enzyme called CYP3A4/5, or certain other drug types (including some cholesterol and heart medications), unless those medications have been stopped for a sufficient period beforehand (confirm specific medications and timeframes with the trial site).
• People currently receiving erythropoiesis-stimulating agents (medications that stimulate red blood cell production).

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