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Trial record 42 of 703 for:    Sickle Cell Disease

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

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ClinicalTrials.gov Identifier: NCT00343954
Recruitment Status : Unknown
Verified June 2006 by Angiogenix.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2006
Last Update Posted : June 23, 2006
Sponsor:
Information provided by:
Angiogenix

Tracking Information
First Submitted Date  ICMJE June 21, 2006
First Posted Date  ICMJE June 23, 2006
Last Update Posted Date June 23, 2006
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2006)
  • PK and PD responses to L-citrulline
  • Endpoints will be determined as change from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2006)
Assessment of safety and tolerability of L-citrulline,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease
Official Title  ICMJE Phase 1 Pharmacokinetic and Pharmacodynamic Responses to Oral L-Citrulline in Patients With Sickle Cell Disease
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 sickle cell disease but otherwise healthy, will be enrolled in the study.

PK measurements include plasma concentrations of L-citrulline, L-arginine, L-ornithine, and L-proline following the first dose of orally administered L-citrulline and after four weeks of twice daily administration of the drug.

PD measurements include intercellular and vascular adhesion molecules (ICAM, VCAM, and E-selectin), surrogate markers of sickle cell disease activity, and PAT, a measurement of vascular function.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE Drug: L-citrulline tablets, 1000 mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June 21, 2006)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343954
Other Study ID Numbers  ICMJE ANGX-3227-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Angiogenix
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lakshmanam Krishnamurti, MD Children's Hospital of Pittsburgh, Univ. of Pittsburgh Medical Center
PRS Account Angiogenix
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP