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Obeticholic Acid for Familial Adenomatous Polyposis
Study Summary
This trial will test if a new drug, obeticholic acid, can help treat Familial Adenomatous Polyposis, a condition that causes growths in the colon.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT02430077Trial Design
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Who is running the clinical trial?
Media Library
- I have acute cholecystitis or a blockage in my bile ducts.I have polyps in my duodenum or rectum that can't be counted.I am not pregnant, breastfeeding, and if capable of childbearing, I agree to use reliable contraception.I have previously used the drug being studied.I do not have any severe or worsening health conditions that are not under control.I do not have any unmanaged ongoing illnesses.My biopsy shows high-grade dysplasia or cancer.I have a chronic liver condition.I am not taking any drugs that are not allowed in the study.I am 18 years old or older.My cholesterol levels are not under control.I do not have any serious health or mental conditions that could affect my safety in the trial.I have FAP affecting my duodenum and rectum, confirmed by genetic or clinical diagnosis.My lower bowel is intact or I have had specific types of bowel surgery.I haven't had signs of active cancer for at least 6 months.I am fully active and can carry on all my pre-disease activities without restriction.My organ and bone marrow functions are normal.My screening showed I have moderate to severe duodenal polyps.
- Group 1: Group 1: Obeticholic Acid
- Group 2: Group 2: Placebo
- 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
How many participants are currently taking part in this clinical trial?
"Unfortunately, the recruitment period for this trial is now closed. It was initially launched in March of 2022 and last updated on November 18th 2021. If you are considering other studies, 897 trials associated with colorectal cancer have open enrollment periods and 6 investigations related to Obeticholic Acid are actively searching for participants."
Are applications still being accepted for this clinical experiment?
"As detailed on clinicaltrials.gov, recruitment for this trial has been suspended - the project was first posted on March 31st 2022 and last updated November 18th 2021. Although it is not currently searching for participants, 903 other studies are actively recruiting at the moment."
Has Obeticholic Acid been granted sanction by the FDA?
"Our team at Power concluded that Obeticholic Acid is relatively safe, assigning it a score of 1. This assessment was made due to its Phase 1 trial status, meaning there are limited data supporting both its efficacy and safety."
Has a similar trial ever been conducted before this one?
"Since 2015, Obeticholic Acid has been the subject of extensive clinical investigation. The initial trial was conducted by Intercept Pharmaceuticals and included 2480 patients. Following a successful Phase 3 approval in 2015, there are currently 6 active studies for this drug spanning across 31 nations and 142 cities."
Are there numerous sites within the state that are conducting this clinical trial?
"Currently, there are 4 locations taking part in this study - Boston, Phoenix and Ann Arbor plus an additional site. To achieve optimal convenience for participants, it is recommended to select the closest clinic available."
Are there prior studies that have analyzed the effects of Obeticholic Acid?
"Obeticholic Acid was initially evaluated at the Gastroenterology Department Hull Royal Infirmary in 2015. Since then, 18337 clinical trials have been completed and 6 current studies are underway--many of which are taking place out of Boston, MA."
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