Sickle Cell Disease Clinical Trial
Official title:
Phase 1 Pharmacokinetic and Pharmacodynamic Responses to Oral L-Citrulline in Patients With Sickle Cell Disease
NCT number | NCT00343954 |
Other study ID # | ANGX-3227-01 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 1 |
First received | June 21, 2006 |
Last updated | June 21, 2006 |
Verified date | June 2006 |
Source | Angiogenix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate PK and PD responses to L-citrulline given orally for four weeks to patients with sickle cell disease who are otherwise healthy.
Status | Not yet recruiting |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: 1. 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 2. Diagnosis of sickle cell anemia (Hb SS) 3. For female of child-bearing potential, a negative serum pregnancy test and using an adequate method of contraception 4. 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 Criteria: 1. History of sickle-cell–related pain crisis within two weeks of study 2. Pregnant or breast feeding 3. Transfusion within last 90 days 4. Creatinine >1.5 X upper limit of normal 5. SGPT > 2 X upper limit of normal 6. History of allergic reaction to arginine or citrulline product 7. Requires chronic medication other than study drug that cannot be discontinued during the study period 8. Unable to take or tolerate oral medications 9. Unreliable venous access 10. Noncompliant with regular care 11. Participation in an investigational drug or medical device study within previous 30 days 12. In the opinion of the investigator is not a good candidate for participation in the study |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center Health System | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Angiogenix |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PK and PD responses to L-citrulline | |||
Primary | Endpoints will be determined as change from baseline | |||
Secondary | Assessment of safety and tolerability of L-citrulline, |
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