Recruiting
Phase 1

Quercetin

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07433621

Conditions

XIAP Deficiency

Eligibility Criteria

Sex: Male

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Quercetin

Study Details

Brief summary:

The purpose of the study is to evaluate safety and tolerability of oral quercetin in reducing inflammation in male patients with XIAP deficiency. Quercetin is a naturally occurring antioxidant that has many properties including the ability to decrease inflammation in other diseases.

Conditions

XIAP Deficiency

Study ID

NCT07433621

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 2+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male patients
  • Diagnosis of XIAP deficiency
  • Patients ≥2 years of age
  • Serum IL-18 ≥600 pg/mL (approximately 25% above the lab-defined upper limit of normal of 477 pg/mL)
  • Able to take enteral medication

Exclusion Criteria:

  • Renal failure requiring dialysis
  • Total bilirubin >3 mg/dl and/or SGPT >300 at time of enrollment
  • Patients receiving digoxin therapy, who are unable to discontinue treatment due to medical reasons
  • Patients receiving fluoroquinolone therapy, who are unable to discontinue treatment due to medical reasons
  • Patients who are at risk of pregnancy or fathering a child and are unable to use acceptable methods of birth control during the length of the study
  • Patients who have received quercetin or any over the counter anti-oxidant supplementation within last 1 month
  • Patients with unstable disease status or other medical issues requiring hospitalization or rapid escalation of medical care
  • Participating in another therapeutic study for XIAP deficiency

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Quercetin

All subjects will receive a weight adjusted dose of quercetin for a maximum total daily dose of 4000mg/day, divided twice a day.

Interventions

Quercetin

Quercetin will be administered orally at a weight adjusted dose for a maximum total daily dose of 4000mg/day, divided twice a day. If the patient is 70 kg or more, the dose will automatically be assigned at the maximum dose of 4000mg/day. Patients will be instructed to mix quercetin with a small amount of yogurt or other preferred food for ingestion.

Primary outcome measure

  • Safety of quercetin in patients with XIAP deficiency [ Time Frame: 6 months ]
  • Tolerability of quercetin in patients with XIAP deficiency [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kelly McIntosh

513-803-0460Kelly.mcintosh@cchmc.org

Richard Cooper

513-803-7450richard.cooper@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Kelly McIntosh

513-803-0460kelly.mcintosh@cchmc.org

Richard Cooper

513-803-7450richard.cooper@cchmc.org

Principal Investigator:

Rebecca Marsh, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-03-27.