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Amino Acid

L-Citrulline for Sickle Cell Disease

Phase 1

Waitlist Available

Led By Lakshmanam Krishnamurti, MD

Research Sponsored by Angiogenix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of sickle cell anemia (Hb SS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing L-citrulline as a possible treatment for sickle cell disease in otherwise healthy patients.

Who is the study for?

This trial is for individuals with sickle cell anemia (Hb SS) who are 10 years or older, generally healthy, and not currently in a pain crisis. Women must test negative for pregnancy and use contraception. Participants should be able to take oral medication and have no recent transfusions or participation in other trials.Check my eligibility

What is being tested?

The study tests the body's response to L-citrulline, an amino acid given orally over four weeks to patients with sickle cell disease. It aims to understand how the drug is processed (PK) and its effect on the body (PD).See study design

What are the potential side effects?

While specific side effects of L-citrulline are not detailed here, common ones may include stomach discomfort, heartburn, changes in blood pressure or electrolytes. Individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sickle cell anemia (Hb SS).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endpoints will be determined as change from baseline

PK and PD responses to L-citrulline

Secondary outcome measures

Assessment of safety and tolerability of L-citrulline

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AngiogenixLead Sponsor

1 Previous Clinical Trials

160 Total Patients Enrolled

Lakshmanam Krishnamurti, MDPrincipal InvestigatorChildren's Hospital of Pittsburgh, Univ. of Pittsburgh Medical Center

Media Library

L-Citrulline (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT00343954 — Phase 1

Sickle Cell Disease Research Study Groups:

Sickle Cell Disease Clinical Trial 2023: L-Citrulline Highlights & Side Effects. Trial Name: NCT00343954 — Phase 1

L-Citrulline (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00343954 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what criteria must individuals adhere to be admitted into this clinical study?

"To be eligible for the experiment, participants must possess anemia and sickle cell while being in between 10 to 20 years old. The research team is looking to recruit a total of 12 persons."

Answered by AI

Does this trial include seniors above the age of eighty-five?

"This clinical trial has specified that the eligible subject pool for this study is aged between 10 and 65. In total, 131 participants under 18 years old can take part in the trials as well as 85 seniors over 65."

Answered by AI

What have been the reported safety outcomes associated with this treatment?

"The safety of this intervention is assessed to be a 1 due to its early-phase status. While there are preliminary data for efficacy, the data supporting safety has yet to be fully evaluated."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "PK and PD Responses to Oral L-Citrulline in Patients With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00343954.

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