Rifaximin to Modify the Disease Course in Sickle Cell Disease

Exclusion Criteria

• •1. Pregnant or lactating. For female subjects of child-bearing potential, the subject must agree to avoid pregnancy during the rifaximin study period and to practice a recognized form of birth control during this period (e.g. barrier, birth control pills, abstinence).
• •2. Life expectancy of \< 12 months.
• •3. History of allergy to rifaximin.
• •4. Patients with newly developed abnormal vital signs or abnormal physical examination (outside the signs that are expected in patients with SCD).
• •5. Patients in active VOC.
• •6. Patients with a baseline prothrombin time International Normalized ratio (INR) \>2.0.
• •7. Patients who receive any blood products within three weeks of the screening visit.
• •8. Patients with uncontrolled liver disease or renal insufficiency, colitis, or inflammatory bowel disease.
• •9. Patients with HIV, or other concomitant immunodeficiency.
• •10. Patients on penicillin prophylaxis or antibiotics for treatment of infection.
• •11. Patients with significant medical condition that require hospitalization (other than sickle cell VOC) within two months of the screening visit.
• •12. Patients currently taking or has been treated with an investigational drug within 30 days of the screening visit.
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