NCT04474626

Isoquercetin in Sickle Cell Anemia

Single-arm Phase 2 Study of Oral Isoquercetin in Sickle Cell Disease

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jeffrey Zwicker, MD · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This research study is being done to assess the safety and effectiveness of isoquercetin to reduce levels of soluble P-Selectin in patients with sickle cell disease. Isoquercetin is a naturally occurring flavonoid-or vitamin. You will find quercetin and isoquercetin in fruits and vegetables. The names of the study drug involved in this study are/is: \- Isoquercetin

Detailed description

This is a single-arm phase 2 study in adults with Sickle Cell Disease (SCD) to assess the effect of oral isoquercetin on biomarkers of endothelial and platelet activation, inflammation and ongoing blood coagulation. * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * The names of the study drug involved in this study are/is: Isoquercetin * Participants will receive study treatment for 1 year and will be followed for 30 days after the last dose. * This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. * The U.S. Food and Drug Administration (FDA) has not approved isoquercetin as a treatment for any disease.

Conditions

• Sickle Cell Disease
• Sickle Cell-Beta0-Thalassemia

Interventions

Type	Name	Description
DRUG	Isoquercetin	Oral, 1 time per day, per predetermined dosed per 28 treatment cycle.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2020-07-17
• Last updated: 2021-01-11

Regulatory

• FDA-regulated drug study