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Obeticholic Acid for Non-alcoholic Fatty Liver Disease (REGENERATE Trial)
REGENERATE Trial Summary
This trial is testing a new drug to see if it can improve the liver health of patients with NASH who have liver fibrosis.
- Non-alcoholic Fatty Liver Disease (NAFLD)
REGENERATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 10 Patients • NCT02430077REGENERATE Trial Design
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- Your weight has not significantly changed recently.You have a sudden inflammation in your gallbladder or a blockage in your bile ducts.Your body mass index (BMI) is higher than 45, which means you are severely overweight.You currently drink a lot of alcohol or have a history of drinking a lot of alcohol.You have other liver diseases like alcoholic liver disease, hepatitis B or C, or other specific liver conditions.Your weight should not be changing rapidly.
- Group 1: 25 mg Obeticholic Acid
- Group 2: 10 mg Obeticholic Acid
- Group 3: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you tell me how many different research facilities are participating in this project?
"100 locations, including the Liver Wellness Center in Little Rock, UF Hepatology Research at CTRB in Gainesville, and Mayo Clinic in Rochester are participating."
Could you please list other studies that have included Obeticholic Acid?
"As it stands, there are 7 ongoing studies that involve Obeticholic Acid. Out of these clinical trials, 2 are still in Phase 3. The majority of research regarding Obeticholic Acid takes place in Changchun, Jilin; however, there are a total of 424 research sites for this medication."
Can new patients sign up for this research project?
"This particular trial is no longer accepting patients. The study was first announced on September 22nd, 2015 and the most recent update was November 1st, 2022. There are currently 244 other trials recruiting participants with non alcoholic steatohepatitis (nash) and 7 for Obeticholic Acid if you are interested in participating in a clinical trial."
How many participants are allowed in this research project?
"Unfortunately, this study is not currently searching for patients. According to the clinical trial's website, it was initially posted on September 22nd, 2015 and updated November 1st, 2020. There are presently 244 studies actively enrolling patients with non alcoholic steatohepatitis (nash) and 7 trials for Obeticholic Acid actively recruiting participants."
Can people of any age participate in this research?
"This study is taking in individuals that are above the age of 18 and younger than 85."
Obeticholic Acid has been used to treat what medical conditions?
"Obeticholic Acid has been studied in multiple Phase 3 clinical trials, meaning that there is some data supporting its efficacy and safety. Our team at Power estimates the safety of Obeticholic Acid to be a 3 on a scale from 1 to 3."
How can I sign up to be a subject in this clinical trial?
"The inclusion criteria for this clinical trial requires that patients have non alcoholic steatohepatitis (nash) and are between 18-85 years old. A total of 2480 participants will be accepted into the study."
Does this medical experiment explore new territory?
"Intercept Pharmaceuticals first sponsored a study for Obeticholic Acid in 2015, which then led to the drug receiving Phase 3 approval that same year. Since then, there have been 7 active clinical trials involving the medication across 142 cities and 31 countries."
Who else is applying?
What state do they live in?
How old are they?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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