Clinical Trial: A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Dose Escalation Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome

Brief Summary: Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from sickling of red blood cells, that can lead to pain or organ complications such as acute chest syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound important for dilating the blood vessel wall. Citrulline is a substance that is known to increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of continuous IV citrulline that can be given to individuals with sickle cell disease experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side effects.

Detailed Summary:
Sponsor: University of Mississippi Medical Center

Current Primary Outcome:

• Adverse events [ Time Frame: 30 days ]
  The number and severity of adverse event will be determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)
• Plasma citrulline level [ Time Frame: 48 hours ]
  Plasma citrulline levels will be evaluated at certain time points to evaluate the pharmacokinetic profile of continuous intravenous citrulline

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Mississippi Medical Center

Dates:
Date Received: February 29, 2016
Date Started: February 2016
Date Completion:
Last Updated: February 29, 2016
Last Verified: February 2016