PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease

Status unconfirmed · Phase 1

Conditions studied: Sickle Cell Disease

In brief

To evaluate PK and PD responses to L-citrulline given orally for four weeks to patients with sickle cell disease who are otherwise healthy.

Key facts

Study ID

NCT00343954

Run by

Angiogenix

People needed

12

Last updated by the study team

2006-06-23

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 10 years of age or older on the day of dosing, and generally healthy as determined by medical history, physical examination, and laboratory test values
• Diagnosis of sickle cell anemia (Hb SS)
• For female of child-bearing potential, a negative serum pregnancy test and using an adequate method of contraception
• Has signed and received a copy of the written informed consent form approved by the investigator's Institutional Review Board (IRB), understands the purposes and risks of the study and agrees to follow the restrictions and schedule of procedures as defined by this protocol

You may not qualify if…

• History of sickle-cell-related pain crisis within two weeks of study
• Pregnant or breast feeding
• Transfusion within last 90 days
• Creatinine >1.5 X upper limit of normal
• SGPT > 2 X upper limit of normal
• History of allergic reaction to arginine or citrulline product
• Requires chronic medication other than study drug that cannot be discontinued during the study period
• Unable to take or tolerate oral medications
• Unreliable venous access
• Noncompliant with regular care
• Participation in an investigational drug or medical device study within previous 30 days
• In the opinion of the investigator is not a good candidate for participation in the study

Where it is running

• Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center Health System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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