FDA Approved Drug Study for Hepatitis B Virus Infection in African American and Hispanic Population

The University of Chicago and Dr. Smruti Mohanty are conducting a study to show the effectiveness of an approved drug in treating Chronic Hepatitis B (HBV) infections in African American and Hispanic adults. The drug and dosage used in this study have been approved by the Food and Drug Administration (FDA) for the treatment of HBV.

If you meet the conditions required to participate in this study and decide to participate, you will be asked to visit the clinic every four to six weeks (for up to 52 weeks) to undergo the following tests and procedures: physical exams, urine pregnancy testing if you are a woman of childbearing potential, and laboratory tests requiring blood draws. During this time, you will be asked to take 0.5 milligrams of the study drug daily. When you complete 52 weeks of study drug, you will be asked to come for a final visit at week 58. If you decided to withdraw from the study early, you will be followed off the study for up to 24 weeks.

Your Hepatitis B may stabilize or improve while you are a part of this study. Previous studies conducted on the study drug show that it significantly decreases the amount of Hepatitis B virus in the blood. After one year of treatment there is less inflammation in the liver of most subjects and a majority of subjects have improvements in their liver function tests.

However, it is possible that you may receive no benefit from being in this study, but you may be helping future patients by providing important information about the treatment of chronic Hepatitis B virus infection.

Participation Details

Initial selection criteria include:

• Must self-identify as African American or Hispanic
• Must be at least 18 years of age
• Must never have received previous treatment for Hepatitis B
• Must meet study medical criteria as evaluated by Dr. Mohanty

Study Director: Dr. Smruti Mohanty
Department: Medicine, Section of Gastroenterology, Center for Liver Diseases

For more information contact:
Katie Wherity, RN
(773) 702-4477

Heather Jernstad RN
(773) 702-2788

IRB: #14948A