A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease
Completed · Phase 1
Conditions studied: Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT02314689
- Run by
- Suvankar Majumdar
- People needed
- 4
- Starts
- 2015-01-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2019-09-03
Who can join
Age: 18 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)
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 >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
Where it is running
- University of Mississippi Medical Center — Jackson, Mississippi, United States
Full record on ClinicalTrials.gov
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