Drug Study for Patients with Hepatitis B
Study Summary
The University of Chicago and Dr. Smruti Mohanty are conducting a research study to determine if a new study drug is safe and able to be tolerated (able for the body to accept it). The new drug is an injectable solution that consists of DNA (genetic material) and a chemical compound. The chemical compound is designed to carry the drug to the liver. The DNA from the drug will produce small pieces of RNA (another type of genetic material) in the liver cells. These small pieces of RNA are thought to stop the Hepatitis B virus from reproducing in those liver cells that have been infected by the virus. This study drug is considered an experimental drug and has not been approved by the U.S. Food and Drug Administration (FDA).
If you qualify to participate in this study based on a screening visit, you will be assigned to one of five groups taking different doses of the study drug. You will receive the first dose at the clinic and be asked to stay overnight at the General Clinic Research Center (GCRC) for 24-hour observation. During this time, you will undergo various physical exams, blood draws, ECGs and urine tests to monitor your safety. You will receive a phone call at least one day after being discharged from the GCRC and again at two days. You will be asked to return for seven follow up visits in the span of 42 weeks so that physical exams, blood draws, ECGs, and urine tests allow study staff to monitor your health.
You may not benefit directly from this research since this is a clinical research study that is designed to test the safety and tolerability of an experimental drug and is not designed to prove the drug's effectiveness. You should not expect a beneficial effect on your Hepatitis B from participating in this study. However, the information learned about the study drug and how it works may helpful to patients with Hepatitis B in the future.
Participation Details
Initial selection criteria include:
- Must be at between the ages of 21 and 70
- Must not be pregnant or breast feeding during the study
- Must be available for clinic visits for the duration of the study
- Must meet study medical criteria as evaluated by Dr. Mohanty
Study Director: Dr. Smruti Mohanty
Department: Hepatology (GI)
For more information contact:
Katie Wherity, RN
kwherity@medicine.bsd.uchicago.edu
(773) 702-4477
IRB: #15658A
