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

Status:

UNKNOWN

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

Lead Sponsor:

Angiogenix

Conditions:

Sickle Cell Disease

Eligibility:

All Genders

10+ years

Phase:

PHASE1

Brief Summary

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

Detailed Description

Phase 1, single center, open label, multiple-dose study consisting of a screening period followed by four weeks of treatment. At least 12 male and female patients, 10 years of age or older, with sickl...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00343954

Last Update

June 23 2006

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