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Farnesoid X receptor (FXR) agonist

Obeticholic Acid for Familial Adenomatous Polyposis

Phase 1

Waitlist Available

Led By Eduardo Sanchez, MD, PhD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of intact rectum or ileo-rectal anastomosis (IRA) or ileal pouch-anal anastomosis (IPAA)

Age ≥ 18 years

Must not have

Individuals with acute cholecystitis or biliary obstruction

Duodenal or rectal/pouch polyp burden that is not quantifiable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

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.

Who is the study for?

Adults diagnosed with Familial Adenomatous Polyposis (FAP) having more than 100 adenomas, a family history of FAP, or specific genetic markers. Participants must have normal organ and marrow function, no active cancer for the past 6 months, and agree to use contraception. Excluded are those with severe health issues, uncontrolled hyperlipidemia, pregnant or breastfeeding women, and anyone on certain medications.

What is being tested?

The trial is testing Obeticholic Acid (OCA), comparing its effects against a placebo in treating FAP. The goal is to see if OCA can improve conditions associated with FAP such as duodenal polyposis and rectal polyps.

What are the potential side effects?

While not specified here, potential side effects of OCA may include itching, fatigue, abdominal pain or discomfort; however exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lower bowel is intact or I have had specific types of bowel surgery.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have FAP affecting my duodenum and rectum, confirmed by genetic or clinical diagnosis.

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My organ and bone marrow functions are normal.

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My screening showed I have moderate to severe duodenal polyps.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have acute cholecystitis or a blockage in my bile ducts.

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I have polyps in my duodenum or rectum that can't be counted.

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I am not pregnant, breastfeeding, and if capable of childbearing, I agree to use reliable contraception.

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I have previously used the drug being studied.

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I do not have any severe or worsening health conditions that are not under control.

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I do not have any unmanaged ongoing illnesses.

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My biopsy shows high-grade dysplasia or cancer.

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I am not taking any drugs that are not allowed in the study.

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My cholesterol levels are not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the effect of treatment with OCA versus treatment with placebo on duodenal polyp burden (sum of polyp diameters) in participants with FAP.