A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease | NCT02314689 | Trialant
CompletedInterventionalPhase 1Updated Sep 3, 2019
A Dose Escalation Study of Intravenous L-citrulline in Steady-state Sickle Cell Disease
ClinicalTrials.gov ID
NCT02314689
Lead Sponsor
Suvankar MajumdarOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
4Actual
Last Update Posted
Sep 3, 2019Actual
Start Date
Jan 2015Actual
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
Brief Summary
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.
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