Expired Study
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Jackson, Mississippi 39216


Purpose:

The purpose of this study is to assess the maximum tolerated dose, safety and pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in steady-state sickle cell disease.


Criteria:

Inclusion Criteria: - Sickle cell disease genotypes (HbSS, HbS/β° thalassemia, HbS/β+thalassemia, HbSC) Exclusion Criteria: - 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 >1.5mg/dL - Patients with an inability to give consent will be excluded - Medications that are known to be contra-indicated with use of L-citrulline (concurrent use of hydroxyurea will be allowed). - History of diabetes due to risk of electrolyte imbalance


NCT ID:

NCT02314689


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Jackson, Mississippi 39216
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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