PK and PD Responses to Oral L-Citrulline in Patients With... | NCT00343954

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

NCT00343954

Sponsor

Angiogenix

Status

Unknown status

Last Update Posted

Jun 23, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Sickle Cell Disease

Interventions

L-citrulline tablets, 1000 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 21, 2006

First Submission Date that Met QC Criteria

Jun 21, 2006

First Posted Date

Jun 23, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2006

Last Update Posted Date

Jun 23, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
L-citrulline tablets, 1000 mg	Drug

Measure	Description	Time Frame
Assessment of safety and tolerability of L-citrulline,

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lakshmanam Krishnamurti, MD	Children's Hospital of Pittsburgh, Univ. of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center Health System		Pittsburgh	Pennsylvania	15213	United States

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

ID	Term
D000599	Amino Acids, Diamino
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Measure	Description	Time Frame
PK and PD responses to L-citrulline
Endpoints will be determined as change from baseline