What side effects are associated with this type of intervention?

Common treatments for Primary Sclerosing Cholangitis (PSC) include antibiotics like Vancomycin, which can cause side effects such as nephrotoxicity (kidney damage) and ototoxicity (hearing damage). Other treatments, such as immunosuppressive agents like cyclosporine, may lead to increased susceptibility to infections, hypertension, and renal dysfunction. Antifungal agents, although not directly used for PSC, can cause liver toxicity and gastrointestinal disturbances. It is essential to monitor patients closely for these adverse effects during treatment.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Primary Sclerosing Cholangitis (PSC). Vancomycin, which inhibits bacterial cell wall synthesis, is being studied for its potential effectiveness in treating PSC. This antibiotic is being explored due to its immunomodulatory and anti-inflammatory properties, which may benefit PSC patients. Further research and clinical trials are necessary to establish its efficacy and safety for this indication.

What other types of research exist?

Currently, there are no specific novel alternatives to Vancomycin mentioned for Primary Sclerosing Cholangitis in the provided context. However, ongoing research into immunosuppressive medications and bile acid therapies, such as ursodeoxycholic acid (UDCA), may offer potential alternatives. Patients should consult with their healthcare provider for the latest treatment options and emerging therapies.

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Vancomycin for Primary Sclerosing Cholangitis

Phase 2 & 3

Waitlist Available

Led By Elizabeth Carey, MD

Research Sponsored by Elizabeth Carey

Eligibility Criteria Checklist

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

Must have

Diagnosis of PSC consistent with the guidelines published by the American Association for the Study of Liver Diseases (AASLD). All subjects must have an elevated serum ALP of at least 1.5 times upper limit of normal at baseline plus cholangiographic evidence of PSC, as demonstrated by magnetic resonance imaging, endoscopic retrograde cholangiography, direct cholangiography, or liver biopsy.

Male or female subject age 18-76 years

Must not have

PSC with concomitant autoimmune hepatitis (AIH) and/or primary biliary cholangitis (previously known as primary biliary cirrhosis)

Secondary sclerosing cholangitis (SSC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Summary

This trial is testing if vancomycin, an antibiotic, is safe and effective for adults with primary sclerosing cholangitis (PSC). There are reports of vancomycin improving liver health in patients with PSC. The study will measure if vancomycin can improve liver health. Researchers will also look at changes in gut health and inflammation to see how they relate to liver health.

Who is the study for?

Adults aged 18-76 with Primary Sclerosing Cholangitis (PSC) can join this trial. They must have certain liver test results and imaging that confirms PSC without other liver diseases or complications like cancer. Stable doses of specific medications are allowed, but no antibiotics in the last 3 months or recent experimental therapies for PSC without a washout period.

What is being tested?

The trial is testing if vancomycin is safe and effective for treating PSC compared to a placebo. Participants will be randomly assigned to receive either vancomycin or an inactive substance, with neither the participants nor the researchers knowing who receives which treatment until after the study ends.

What are the potential side effects?

Vancomycin may cause side effects such as allergic reactions, kidney problems, hearing issues, and infusion-related reactions like redness and pain where injected. The severity of these side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with PSC and meet the AASLD guidelines, including high ALP levels and confirmed by imaging or biopsy.

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I am between 18 and 76 years old.

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I have PSC, with or without a condition like ulcerative colitis or Crohn's disease.

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I have PSC with high ALP levels and confirmed by specific liver tests.

Exclusion Criteria

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

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I have PSC and may also have autoimmune hepatitis or primary biliary cholangitis.

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I have been diagnosed with secondary sclerosing cholangitis.

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I have a liver condition not related to bile duct blockage.

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I have a metabolic liver disease like Wilson's disease or hemochromatosis.

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I have a genetic liver condition like α-1 antitrypsin deficiency.

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I have been diagnosed with IgG4-related cholangitis.

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I have had a liver transplant or might need one soon, or my liver is severely damaged.

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My kidneys are not working well, with a creatinine clearance under 60 mL/min.

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I have advanced PSC with complications like confusion, high blood pressure in liver veins, or kidney and lung issues.

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I have hepatitis B.

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I am currently being treated with antibiotics for a bile duct infection.

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My cancer is confirmed as bile duct cancer through specific tests.

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I am living with HIV/AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Alkaline phosphatase at 12 months

Alkaline Phosphatase

Alkaline phosphatase at 3 months post treatment = 21 months

+2 more

Secondary study objectives

Fibroscan, cholangiography

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VancomycinExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

2020

Completed Phase 4

~7920

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Primary Sclerosing Cholangitis (PSC) include vancomycin, which inhibits bacterial cell wall synthesis, potentially reducing bacterial endotoxins that contribute to inflammation and fibrosis. Ursodeoxycholic acid (UDCA) improves bile flow and reduces liver enzyme levels, while immunosuppressive agents like glucocorticoids reduce inflammation. These treatments are important for PSC patients as they target specific disease mechanisms, potentially improving outcomes and quality of life.

β-Adrenoceptor blockade in sclerosing cholangitis of Mdr2 knockout mice: antifibrotic effects in a model of nonsinusoidal fibrosis.