Isoquercetin in Sickle Cell Anemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04474626|
Recruitment Status : Not yet recruiting
First Posted : July 17, 2020
Last Update Posted : July 17, 2020
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:
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Sickle Cell-Beta0-Thalassemia||Drug: Isoquercetin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-arm Phase 2 Study of Oral Isoquercetin in Sickle Cell Disease|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2024|
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits
- ISOQUERCETIN: Oral Study Drug, 1 time per day, per predetermined dosed per 28 treatment cycle.
This will continue for up to 337 days.
Oral, 1 time per day, per predetermined dosed per 28 treatment cycle.
Other Name: IQC-950AN
- Change in sP Selectin levels with isoquercetin [ Time Frame: baseline to 28 Days ]Comparisons between baseline and follow-up measurements (i.e. change in sP-Selectin), will be performed using a two-tailed, paired t-test analyses.
- Platelet dependent thrombin generation (coagulation) [ Time Frame: baseline to 1 year ]Laboratory values at baseline and subsequent monthly follow-up time points will be modeled using linear mixed effects regression with an autoregressive covariance structure.
- sE-selectin (adhesion)-Biomarker [ Time Frame: baseline to 1 year ]Laboratory values at baseline and subsequent monthly follow-up time points will be modeled using linear mixed effects regression with an autoregressive covariance structure.
- C-reactive protein CRP [ Time Frame: baseline to 1 year ]Laboratory values at baseline and subsequent monthly follow-up time points will be modeled using linear mixed effects regression with an autoregressive covariance structure.
- Number of Participants With Treatment-Related Adverse Events [ Time Frame: start of study treatment up to 13 months ]Sickle cell events such as SCPC, uncomplicated pain crisis, hospitalizations, emergency room visits, transfusions, acute chest syndrome and transfusion support will be summarized as annualized numbers. Statistical comparisons will be made for each patient relative to the number from the previous year using a Wilcoxon rank-sum test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474626
|Contact: Jeffrey Zwicker, MDemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Contact: Maureen Achebe, MD 617-732-5048 firstname.lastname@example.org|
|Principal Investigator: Maureen Achebe, MD|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Contact: David Kuter, MD 617-726-8743|
|Principal Investigator: David Kuter, MD|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Contact: Jeffrey Zwicker, MD 617-667-9299 email@example.com|
|Principal Investigator: Jeffrey Zwicker, MD|
|Principal Investigator:||Jeffrey Zwicker, MD||Beth Israel Deaconess Medical Center|