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Flavonoid
Fixed Dose Flavonoid Isoquercetin on Thrombo-Inflammatory Biomarkers in Subjects With Stable Sickle Cell Disease
Phase 2
Waitlist Available
Led By Arun S Shet, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 56
Summary
This trial is testing isoquercetin, a dietary supplement, to see if it can reduce inflammation and blood clotting in adults with Sickle Cell Disease. People with SCD often have higher risks of blood clots and inflammation. Isoquercetin works by lowering certain proteins that cause these issues.
Eligible Conditions
- Sickle Cell Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 56
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change in the Plasma Soluble P-selectin Level
Secondary study objectives
Mean Change in D-Dimer
Mean Change in Plasma Protein Disulfide Isomerase Activity
Mean Change in Tissue Factor Vesicle Procoagulant Activity
+6 moreSide effects data
From 2019 Phase 2 & 3 trial • 64 Patients • NCT0219523214%
Diarrhea
7%
Nausea
4%
Constipation
4%
Epistaxis
4%
Hyponatremia
4%
Weight loss
4%
Bruising
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A (Isoquercetin 500 mg)
Cohort B (Isoquercetin 1000 mg)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants with Sickle Cell Disease Receiving IsoquercetinExperimental Treatment1 Intervention
Isoquercetin 1000 mg, once daily by mouth for 28 days in participants with Sickle Cell Disease.
Group II: Participants with Sickle Cell Disease Receiving PlaceboPlacebo Group1 Intervention
Placebo once daily, by mouth for 28 days in participants with Sickle Cell Disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isoquercetin
2020
Completed Phase 3
~180
Find a Location
Who is running the clinical trial?
Quercis Pharma AGIndustry Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,938 Previous Clinical Trials
47,792,252 Total Patients Enrolled
Arun S Shet, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
4 Previous Clinical Trials
2,175 Total Patients Enrolled