A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled,Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
ID Number 16-0224Principal Investigator(s)
Meena B Bansal
Department(s) or Division(s)
The purpose of this study is to look at how well the study drug OCA (Obeticholic Acid) works for the treatment of NASH with liver fibrosis and also how safe and effective the study drug is when compared to a placebo. A placebo looks like a drug but does not contain the study drug’s active ingredient.
OCA is an investigational medicine. This means that OCA is still being studied. It also means that the Food and Drug Administration (FDA) has not approved OCA for the treatment of Nonalcoholic Steatohepatitis (NASH) in patients who have liver fibrosis. Steatohepatitis is a type of liver disease known as fatty liver where the cells in the liver have abnormal fat buildup. The cause of fatty liver is commonly caused by drinking too much alcohol. There is another form of fatty liver that is not caused by alcohol called nonalcoholic fatty liver. The FDA allows OCA to be used only in research.
Subjects may qualify to take part in this research study because you have been diagnosed with liver fibrosis. Liver fibrosis is a condition caused by the buildup of scar tissue in the liver.
If subjects qualify for the study they will be placed in one of the following three (3) treatment groups at the Baseline visit:
- Group A: Placebo, a "sugar (dummy pill)" that contains no real medication
- Group B: OCA 10 mg
- Group C: OCA 25 mg
Subjects will be randomly assigned by chance (like the flip of a coin) assigned by a computer program to 1 of 3 study treatment groups. Your chance of being randomly assigned to each group is 33%. Approximately 688 participants will be assigned to each study treatment group.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is about 2065.
Subjects participation in this research study is expected to last up to 6 years but could be shorter, depending on when subjects entered the study and how long the study lasts.
Recruiting Patients: Yes