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Quercetin in Children With Fanconi Anemia; a Pilot Study

NCT01720147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-18

No results posted yet for this study

Summary

Fanconi anemia (FA) is an autosomal recessive disease characterized by progressive bone marrow failure (BMF), congenital abnormalities and a predisposition to malignancy.

Conditions

  • Fanconi Anemia

Interventions

DRUG

Quercetin (dietary supplement)

Quercetin will be given orally on a twice a day schedule starting with weight adjusted dose for a maximum total daily dose of 1500 mg/day, for 4 months (16 weeks). Pharmacokinetics (PK) data will be analyzed after each cohort of 3 patients and will be used to optimize the dosing schedule (if required)for subsequent patients. An expansion cohort has been added to the study protocol. Up to 20 patients may be enrolled. The dose utilized will be the same as the max weight adjusted dose that showed biological activity in our last cohort of patients (subjects #10-12 from above).

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Parinda Mehta, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2021-10-26
Completion
2021-10-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720147 on ClinicalTrials.gov