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Amino Acid

L-citrulline for Sickle Cell Anemia

Phase 1 & 2

Recruiting

Research Sponsored by Asklepion Pharmaceuticals, LLC

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected from enrollment to end of study over 18 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with sickle cell disease who are experiencing a medical crisis.

Who is the study for?

This trial is for children and young adults aged 6-21 with sickle cell disease experiencing a vaso-occlusive crisis. Participants must not be in any other clinical trials for sickle cell treatments within the last 3 months, have severe anemia, or recent blood transfusions. Females of childbearing age should test negative for pregnancy and use contraception.Check my eligibility

What is being tested?

The study tests if L-citrulline injections can help manage pain during a vaso-occlusive crisis in sickle cell patients, potentially reducing opiate use and hospital stays. It's a two-part trial; Part 1 determines the best dose, while Part 2 uses that dose to compare against placebo in more subjects.See study design

What are the potential side effects?

Potential side effects of L-citrulline may include digestive issues like nausea or stomach pain, allergic reactions for those sensitive to the drug, changes in blood pressure or heart rate, headaches, or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected from enrollment to end of study over 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected from enrollment to end of study over 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected from enrollment to end of study over 18 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of safety

Change from baseline in amount of overall opioid use

Change in Visual Analogue Scale (VAS) pain score

+3 more

Secondary outcome measures

Duration or length of hospital stay

Preliminary assessment of change of opioid use overall

Preliminary assessment of pain change measured

+1 more

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Arm 1 (L-citrulline)Active Control1 Intervention

25 mg/kg bolus + 9 mg/kg/hr continuous infusion of L-citrulline for up to 7 hours

Group II: Arm 2 (L-citrulline)Active Control1 Intervention

50 mg/kg bolus + 9 mg/kg/hr continuous infusion of L-citrulline for up to 7 hours

Group III: Arm 4 (L-citrulline)Active Control1 Intervention

100 mg/kg bolus + 11 mg/kg/hr continuous infusion of L-citrulline for up to 7 hours

Group IV: Part 2 Arm 1 (L-citrulline)Active Control1 Intervention

Subjects will be randomized to 2 of the doses selected from Part 1 and placebo in a 1:1:1 ratio. L-citrulline will be administered to the active arm.

Group V: Arm 3 (L-citrulline)Active Control1 Intervention

100 mg/kg bolus + 9 mg/kg/hr continuous infusion of L-citrulline for up to 7 hours

Group VI: Part 2 Arm 2 D5 1/2NSPlacebo Group1 Intervention

Subjects will be randomized to 2 of the doses selected from Part 1 and placebo in a 1:1:1 ratio.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Asklepion Pharmaceuticals, LLCLead Sponsor

5 Previous Clinical Trials

450 Total Patients Enrolled

Gurdyal Kalsi, MD, MFPMStudy DirectorAsklepion Pharmaceuticals, LLC

2 Previous Clinical Trials

162 Total Patients Enrolled

Media Library

L-citrulline (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT04852172 — Phase 1 & 2

Vaso Occlusive Crisis Research Study Groups: Arm 1 (L-citrulline), Arm 2 (L-citrulline), Arm 4 (L-citrulline), Part 2 Arm 2 D5 1/2NS, Part 2 Arm 1 (L-citrulline), Arm 3 (L-citrulline)

Vaso Occlusive Crisis Clinical Trial 2023: L-citrulline Highlights & Side Effects. Trial Name: NCT04852172 — Phase 1 & 2

L-citrulline (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04852172 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals have registered for this research project?

"Correct. Clinicaltrials.gov verifies that this medical experiment, which was first added on April 29th 2021, is still actively seeking participants. A total of 120 patients have to be recruited from a single site."

Answered by AI

Are there analogous investigations that have made use of Arm 1 (L-citrulline)?

"At present, there are 4 studies running to evaluate the efficacy of Arm 1 (L-citrulline); none of those trials have advanced to Phase 3 yet. These experiments primarily take place in Durham, North carolina but can be found at other locations as well."

Answered by AI

Are there open slots for eligible participants in this experiment?

"According to the information accessible on clinicaltrials.gov, this research endeavour is currently seeking volunteers. It was initially posted on April 29th 2021 and underwent a recent update of July 27th 2022."

Answered by AI

What are the principal ambitions of this clinical experiment?

"This clinical trial, monitored over approximately 7 hours following enrollment to discharge from the emergency room, will measure changes in Visual Analogue Scale (VAS) pain score. Secondary objectives include evaluating opioid use overall as per standard of care and assessing time to clinical resolution of VOC through sustained VAS scores collected every fifteen minutes. Finally, data collected between ED visit and 30 day follow-up will be used to evaluate duration or length of hospital stay with potential reoccurrence admission."

Answered by AI

Am I able to enroll in this clinical experiment?

"Those looking to join this trial should have anemia and sickle cell, as well as falling between the ages of 6 and 21. In total, 120 participants are being sought after for enrollment."

Answered by AI

Does this research endeavor allow seniors over the age of eighty to participate?

"This medical trial is looking for patients aged 6 to 21. 132 studies are open to people younger than 18 and 88 trials can be accessed by those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

L-citrulline Injection in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting With Vaso-Occlusive Crisis (VOC)

2021. "L-citrulline Injection in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting With Vaso-Occlusive Crisis (VOC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04852172.

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