NCT06635902 Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
| NCT ID | NCT06635902 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Suvankar Majumdar |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 99 participants |
| Start Date | 2024-12-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 99 participants in total. It began in 2024-12-22 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Suvankar Majumdar, MD
PRINCIPAL INVESTIGATOR
Children's National Research Institute
Frequently Asked Questions
Who can join the NCT06635902 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 21 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06635902 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06635902 currently recruiting?
Yes, NCT06635902 is actively recruiting participants. Contact the research team at jbaker5@childrensnational.org for enrollment information.
Where is the NCT06635902 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06635902 clinical trial?
NCT06635902 is sponsored by Suvankar Majumdar. The principal investigator is Suvankar Majumdar, MD at Children's National Research Institute. The trial plans to enroll 99 participants.
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