|Seah Lim, MD PhD|
1 United States site
18 to 70 Years
1. Patients with HbSS, HbSC, or HbS beta thal.
2. Age 18-70 years.
3. More than two hospital admissions for painful VOC in the prior 12 months, whether on
any anti-sickling agents (e.g. hydroxyurea, L-glutamine, or transfusion therapy) or
not. These agents may be continued during the study period. However, subjects are not
allowed to be started on any of these agents during the study period.
4. Ability to comprehend and sign an informed consent. –
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
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.