RecruitingPhase 2NCT06635902

Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease

A Phase 2 Randomized Double-blind, Placebo-controlled Clinical Trial of Intravenous Citrulline for Vaso-occlusive Pain Episode in Hospitalized Patients With Sickle Cell Disease (CONQUER SCD Pain Trial)

Sponsor

Suvankar Majumdar

Enrollment

99 participants

Start Date

Dec 22, 2024

Study Type

INTERVENTIONAL

Conditions

Sickle Cell Disease Vaso-occlusive Pain Episode

Summary

The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are: * Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization * What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain. Participants will: * Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay * After hospital discharge, visit the clinic in about 30 days for checkup and tests

Eligibility

Min Age: 4 YearsMax Age: 21 Years

Inclusion Criteria4

Sickle cell disease (all genotypes)
Patients with sickle cell disease ages 4 to 21 years old
Presence of sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
Able to randomize to study drug/placebo within 12 hours of first dose of parenteral opioid in the Emergency Department

Exclusion Criteria14

Current pain lasting >3 days.
>9 hospitalizations in the prior year
Presence of any other complication related to sickle cell disease requiring the hospitalization such as splenic sequestration, hepatic sequestration, stroke, transient ischemic attack, etc.
History of opioid use disorder, chronic pain or medical regimen requiring daily opioid use.
Severe anemia (hemoglobin <6g/dL)
Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
Alanine/aspartate transferase >2x upper limit of normal laboratory range for age.
Subject has the following serum creatinine:
Age 4 to 13 years > 0.9 mg/dL
Age 14 to 17 years 1.0 mg/dL
Age ≥18 years >1.5mg/dL
Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
Use of L-glutamine
History of allergic reaction to L-citrulline products