A Study of Oral L-citrulline in Sickle Cell Disease

Withdrawn before enrolling · Phase 1

Conditions studied: Sickle Cell Disease

In brief

Sickle cell disease is a genetic red blood cell disorder that can result in blocking of the small blood vessels from sickle shaped red blood cells. This causes pain, the main feature of sickle cell disease. Also, low amounts of nitric oxide can occur in sickle cell disease, a substance important for widening the blood vessel wall and therefore preventing blockage of the small blood vessels. Citrulline is a drug that is known to increase nitric oxide. This is a phase I study of citrulline given by mouth to evaluate the safety, tolerability and appropriate dosing of this medication for individuals with sickle cell disease.

Key facts

Study ID

NCT02659644

Run by

University of Mississippi Medical Center

People needed

0

Starts

2015-12-01

Expected to finish

2017-12-31

Last updated by the study team

2018-06-21

Who can join

Age: 10 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sickle cell disease genotypes (HbSS, HbS/β-thalassemia
• HbS/β+thalassemia, HbSC)
• Patients with sickle cell disease aged 10 to 25 years old
• Patients ages 10 through 17 years of age, whose parents have signed permission, and who provide signed patient assent themselves
• Patients 18 through 25 years of age who provide signed consent.

You may not qualify if…

• Presence of any acute illness defined by fever >100.4°F within the past 48 hours
• Presence of sickle cell pain crisis defined by the presence of pain requiring oral or parental opioid therapy.
• Presence of acute chest syndrome or presence of any other complication related to sickle cell disease requiring hospitalization such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, and patients with diabetes etc.
• Severe anemia (hemoglobin < 5g/dL)
• History of red blood cell transfusion within the last 14 days
• Systemic steroid therapy within the last 48 hours
• Pregnant (as confirmed by a negative urine pregnancy test) or lactating female
• Alanine/aspartate transferase >2x upper limit of normal laboratory range for age.
• Elevated serum creatinine: Age 6 to 13 years > 0.9 mg/dL, Age 14-17 years 1.0 mg/dL, Age >18 years >1.5mg/dL
• Patients with an inability to give assent (ages 10 to 17 years) or consent (ages 18 through 25 years) will be excluded
• History of diabetes due to risk of electrolyte imbalance

Where it is running

• University of Mississippi Medical Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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