Protocol Details

High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	08-DK-0004
Sponsoring Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required	No
Population Exclusion(s)	Children
Keywords	Erythrocytes; Drug Screen; Sickle Cell Trait; Sickle Hemoglobin; Sickle Cell Disease; Natural History
Recruitment Keyword(s)	None
Condition(s)	Sickle Cell Trait; Sickle Cell Disease; Sickle Cell Anemia
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Diabetes and Digestive and Kidney Diseases

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 18 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.

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Eligibility

INCLUSION CRITERIA:

-Patients with sickle cell trait

-Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin

-Healthy volunteers for control experiments

-Age range: adults greater than or equal to 18 years of age

EXCLUSION CRITERIA:

-Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.

-As a safety precaution in handling the blood samples, patients with HIV, Hepatitis B or Hepatitis C will be excluded from the study. HIV, Hepatitis B or Hepatitits C testing will not be done under this study. Participants must be co-enrolled under another NIH protocol where the screening evaluation has been performed.

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
William A. Eaton, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 5 Room 104 5 Center Drive Bethesda, Maryland 20892 (301) 496-6030 eaton@mail.nih.gov	William A. Eaton, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 5 Room 104 5 Center Drive Bethesda, Maryland 20892 (301) 496-6030 eaton@mail.nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT00542230

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