BridgeMD
Prevention study for Barrett Esophagus
Official title Obeticholic Acid for Prevention in Barrett's Esophagus
ClinicalTrials.gov ID: NCT04939051
What this study is testing
What is Obeticholic Acid?
Obeticholic Acid is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for barrett esophagus.
Also referred to as INT-747, Ocaliva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Known diagnosis of histologically-confirmed BE with either no dysplasia, indefinite for dysplasia, or low-grade dysplasia as defined by the presence...
- Adequate Barrett's mucosa, which is defined as at least one sample with \>= 50% intestinal metaplasia in biopsies required to satisfy the endpoints...
- Participants are on proton pump inhibitors (PPI) therapy for \>= 28 days duration
- Age \>= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants \< 18 years of age...
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%)
You likely can't join if
- History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment
- Prior use of OCA
- Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy
- Cutaneous diseases manifesting with severe pruritus
- Individuals with active, known or suspected chronic liver disease including cirrhosis, nonalcoholic steatohepatitis (NASH) with fibrosis or...
- Individuals with acute cholecystitis (defined by a syndrome of right upper quadrant pain, fever, and leukocytosis associated with gallbladder...
See the full eligibility criteria
Who can join
- Known diagnosis of histologically-confirmed BE with either no dysplasia, indefinite for dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and \>= 2 cm of...
- Adequate Barrett's mucosa, which is defined as at least one sample with \>= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study
- Participants are on proton pump inhibitors (PPI) therapy for \>= 28 days duration
- Age \>= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants \< 18 years of age, children are excluded from this study but will be eligible for future...
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 70%)
- Hemoglobin \>= 10g/dL or hematocrit \>= 30 %
- Leukocyte count \>= 3,500/microliter
- Platelet count \>= 100,000/microliter
- Creatinine clearance (calculated if measured is not available) \>= 30mL/min/1.73m\^2
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 1.5 X institutional upper limit of normal (ULN)
- Total bilirubin =\< 1.0 X ULN
- Alkaline phosphatase =\<1.5 X ULN
- Gamma-glutamyl transferase (GGT) =\< 1.5 X ULN
- The effects of OCA on the developing human fetus are unknown. For this reason, all men and women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control...
- Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Non-English speaking participants are allowed to enroll even if they skip answering quality-of-life (QOL)...
- Willing to undergo testing for human immunodeficiency virus (HIV) testing if not tested within the past 6 months
- Willing to undergo hepatitis B and C screening if not tested within the past 6 months
- Willing and able to adhere to the prohibitions and restrictions specified in the approved protocol
- Willingness to moderate alcohol intake (consuming no more than 1 or 2 alcoholic drinks per day for women and men, respectively)
- Participants must have no evidence of active or recurrent invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy...
What rules you out
- History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment
- Prior use of OCA
- Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy
- Cutaneous diseases manifesting with severe pruritus
- Individuals with active, known or suspected chronic liver disease including cirrhosis, nonalcoholic steatohepatitis (NASH) with fibrosis or cirrhosis, primary sclerosing cholangitis, biliary atresia
- Individuals with acute cholecystitis (defined by a syndrome of right upper quadrant pain, fever, and leukocytosis associated with gallbladder inflammation)
- Individuals with a history of pancreatitis or pancreatic abnormalities
- Individuals with hepatic steatosis and velocity \> 1.7 m/sec as determined by liver ultrasound elastography. Results of a right upper quadrant ultrasound with elastography performed within 6 months of starting study...
- Individuals with hyperlipidemia that is not well controlled with the use of pharmacotherapy and/or dietary modifications
- History of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and...
- Individuals with known hypersensitivity, allergies, or intolerance to the study drug or compounds of similar chemical or biologic composition
- Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Individuals with active and untreated hepatitis C virus (HCV) and/or or hepatitis B virus (HBV) infection
- Individuals with HIV infection are eligible for participation if:
- CD4+ count \>= 300/uL
- Viral load is undetectable
- Receiving highly active antiretroviral therapy (HAART) without known or suspected drug interactions with OCA
- Consultation with the participant's infectious disease specialist may be obtained
- Individuals taking the drugs listed below may not be assigned by chance unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less...
- The use of the following drugs or drug classes is prohibited during OCA/placebo treatment
- Investigational agents;
- Bile acid sequestrants (bile acid binding resins): cholestyramine, colestipol, or colesevelam;
- Bile salt efflux pump (BSEP) inhibitors;
- Clozapine;
- Theophylline derivatives;
- Tizanidine;
- Warfarin;
- Hepatotoxic drugs such as amiodarone, sodium valproate, certain herbal/dietary supplements, and long-term doxycycline or tetracycline
- Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contraceptive method. Pregnant women are excluded from this study because OCA is an agent with unknown effects on the developing...
- Participants may not be receiving any other investigational agents
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Chapel Hill, North Carolina, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.