DMID 13-0053 for Patients with NASH and Healthy Volunteers - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn how people with cirrhosis respond to a new antibiotic compared to healthy people.
Who Can Participate in the Study?
Adults (age 18-70) with liver cirrhosis and healthy volunteers who:
- Do not smoke or smoke less than 10 cigarettes per day
- Do not have HIV
- Have not donated blood in the past 30 days
- Do not currently abuse drugs or alcohol
What is Involved?
If you choose to join the study you will:
- Have a screening visit that will last about 3 hours.
- Be randomized, like the flip of a coin, to one of two groups:
-- One group will receive the study antibiotic OR
-- One group will receive a placebo (an inactive substance)
- Have a 3 day (2 night) inpatient stay in the hospital
- Have 4 follow-up outpatient visits that will last about 1 hour each.
-- Have blood drawn at each visit.
- Have ECGs, vital signs, and physical exams performed several times throughout the study.