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Quercetin in Children With Fanconi Anemia; a Pilot Study


Phase 1
N/A
N/A
Open (Enrolling)
Both
Fanconi Anemia

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Trial Information

Quercetin in Children With Fanconi Anemia; a Pilot Study


Inclusion Criteria:



- Diagnosis of FA proven by DEB test

- Able to take enteral medication

Exclusion Criteria:

- Patients with morphological evidence of myelodysplasia or leukemia

- Renal failure requiring dialysis

- Total bilirubin > 3 mg/dl and/or SGPT >200 at time of enrollment

- Patients who are pregnant or breastfeeding or are at risk of pregnancy and are unable
to use acceptable methods of birth control during the length of the study

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Measure the ability to administer twice daily oral quercetin therapy in patients with Fanconi Anemia (FA).

Outcome Time Frame:

4 months (16 weeks)

Safety Issue:

Yes

Principal Investigator

Parinda Mehta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Food and Drug Administration

Study ID:

2011-2049

NCT ID:

NCT01720147

Start Date:

July 2012

Completion Date:

December 2015

Related Keywords:

  • Fanconi Anemia
  • Fanconi Anemia
  • FA
  • Quercetin
  • Anemia
  • Fanconi Anemia
  • Fanconi Syndrome

Name

Location

Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039