A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 25 |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
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.
pharmacokinetics of an investigational drug, intravenous (IV) citrulline, in subjects in
steady-state sickle cell disease.
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
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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