A Study for Those with Chronic Pancreatitis
The purpose of this study is to learn if a study drug called NI-03 (also known as Camostat) can help people with chronic pancreatitis. We want to find out what effects, good or bad, the study drug has on the disease. It has been approved in Japan and has been available by prescription for the treatment of the acute pain associated with chronic pancreatitis. The study drug will not be approved for sale in the United States until tests from studies like this one show that it is safe and effective.
-You are between the ages of 18-80
-You have a diagnosis of chronic pancreatitis
-For males: documented surgical sterilization, sexual abstinence, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required
-For females: documented surgical sterilization, sexual abstinence, postmenopausal status for at least 1 year, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required
The REGENERATE Study - A study to evaluate the effectiveness and safety of a medication (Obeticholic Acid) for those with NASH (nonalcoholic steatohepatitis)
This research study is for those who have nonalcoholic steatohepatitis (NASH) (meaning your liver is swollen and damaged because of a buildup of fat in your liver) and some liver fibrosis (which is damaged and scarred liver tissue). Because of your condition, you may be eligible for a research study on an investigational drug for your condition. The Regenerate Study will assess the safety and effectiveness of the investigational medication obeticholic acid (OCA) compared to placebo in delaying specific medical conditions or health related issues that can occur in patients with nonalcoholic steatohepatitis (NASH) (meaning your liver is swollen and damaged because of a buildup of fat in your liver) and some liver fibrosis (which is damaged and scarred liver tissue).
- Age 18 or older
- Diagnosed with Stage 2 or 3 NASH (nonalcoholic steatohepatitis--meaning your liver is swollen and damaged because of a buildup of fat in your liver) and some liver fibrosis (which is damaged and scarred liver tissue).
If you are eligible and decide to take part in this research study, you will need to complete 1 or 2 screening visits to see if you are eligible to participate in the study. Once the study doctor determines you can participate in the study, you will be asked to come back to the clinic 8 times (for the Month 0 [Day 1] Visit, the Month 1 Visit, the Month 3 Visit, and then every 3 months) for the first 18 months you are in the study and then 2 times per year (every 6 months) for each additional year you are in the study.