Clinical Trial: Blood Sampling for Research Related to Sickle Cell Disease
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease
Brief Summary:
This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease.
Volunteers must be at least 8 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history.
During the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons) of blood.
Because repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children.
Detailed Summary: The critical event leading to serious morbidity in sickle cell disease is the distortion (sickling) and consequent stiffening of red blood cells caused by abnormal hemoglobin. Currently, hydroxyurea is the only approved drug for treating sickle cell disease, but only partially effective. This protocol seeks to identify by high sensitivity in vitro screening methods additional compounds that result in inhibiting sickling of red blood cells. Subjects with sickle cell trait or disease and normal volunteers will be asked to donate blood samples for studies to verify their hemoglobinopathies and then periodically donate small volume samples of fresh blood for use in ongoing high throughput screening tests to identify potentially clinically useful anti-sickling drugs.
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: October 10, 2007
Date Started: October 1, 2007
Date Completion:
Last Updated: April 20, 2017
Last Verified: January 30, 2017
