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Mon, Jun 22 7:00am · Active Clinical Trials for Primary Sclerosing Cholangitis at Mayo Clinic in Primary Sclerosing Cholangitis (PSC)

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Clinical Trials are a fundamental aspect of our research and clinical efforts for Primary Sclerosing Cholangitis (PSC) at Mayo Clinic. At the present time, we have four clinical trials for patients with PSC open for enrollment, listed below:

Ongoing Clinical Trials

Investigation of Vidofludimus Calcium for PSC.  Open label study, 6 month treatment period.  For more details please go to: ClinicalTrials.gov Identifier: NCT03722576

Investigation of Cilofexor (an FXR agonist) for PSC.  Randomized, placebo-controlled study, 96 week treatment period. For more details please go to: ClinicalTrials.gov Identifier: NCT03890120

A Prospective, Randomized, Multi-Centered, Placebo-Controlled Clinical Trial of Oral Vancomycin in Adults with Primary Sclerosing Cholangitis

This phase II, randomized, placebo-controlled clinical trial is designed to examine the safety, tolerability and efficacy of daily dosing (over an 18-month period) with oral vancomycin, using a stepped-up dosing strategy with three increasing doses, on the clinical course, and the progression of PSC, and to compare the treated patients with those on placebo.

Multi-omics of Primary Sclerosing Cholangitis

This translational study seeks to generate the first, multi-omics and comprehensive clinical data resource for PSC. The study aims to define the bigger-picture cellular networks and gene-environment interactions driving PSC by integrating several layers of -omics data. In so doing, we will identify molecular disease signatures, including environmental toxins, metabolism-related chemicals and gut bacteria, unique to PSC patients.

For questions please call Mr. Mitchell Clayton (Clinical research coordinator) 507-284-2698.

Mon, Mar 16 8:52am · A Randomized, Placebo-controlled, Phase II Study of Obeticholic Acid for Primary Sclerosing Cholangitis in Primary Sclerosing Cholangitis (PSC)

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In a recent paper, published in the Journal of Hepatology, Kowdley, et al., reported a randomized, placebo-controlled, dose-finding study of Obeticholic acid (OCA), which has been approved for the therapy of Primary Biliary Cholangitis (PBC). OCA is a potent farnesoid X receptor (FXR) and the study included 76 patients with Primary Sclerosing Cholangitis (PSC) randomized to either placebo (n=25), OCA 1.5-3 mg (n=25), or OCA 5-10 mg (n=26). The primary endpoints of the study were improvement in serum alkaline phosphatase, a potential marker of disease severity, from baseline to week 24, and safety of OCA use. At week 24, serum alkaline phosphatase was significantly reduced with OCA 5-10 mg group vs. placebo group but not significantly reduced with OCA 1.5-3 mg group vs. placebo group. Of note, the overall reduction in serum alkaline phosphatase observed in this study was not lower than that observed with UDCA monotherapy among PSC patients in the past. The most common treatment-emergent adverse event was dose-related pruritus (placebo, 46%; OCA 1.5-3 mg, 60%; OCA 5-10 mg, 67%). No new safety signals were noted. A study limitation was an early termination (due to administrative reasons) of the long term safety extension (LTSE). Because the majority (93%) of the LTSE patients discontinued OCA before the month 24 visit, the number of patients evaluable for all liver biochemistry outcomes declined after month 12 and the results must be interpreted with caution. This is a promising study. Follow-up investigations are needed to validate these findings of OCA use for the future management of PSC patients.

Read the paper from Dr. Kowdley

Mon, Mar 2 9:00am · Effects of Tumor Necrosis Factor Antagonists in Patients on Primary Sclerosing in Primary Sclerosing Cholangitis (PSC)

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In a recent study, published in the journal Clinical Gastroenterology and Hepatology, Hedin, et al., reported the effects of tumor necrosis factor (TNF) antagonists on liver function and efficacy in therapy of inflammatory bowel disease (IBD) among patients with Primary Sclerosing Cholangitis (PSC). This was retrospective study of 141 patients with PSC and IBD receiving treatment with anti-TNF agents (either infliximab or adalimumab) at 20 medical centers across Europe and North America. Anti-TNF treatment produced a response or remission of IBD in 48%, and 23% of patients, respectively. There was no difference in PSC symptom frequency before or following exposure to the drugs. The most common reason for discontinuation of anti-TNF were side effects (18%) and primary non-response of IBD (17%). At 3 months, infliximab-treated patients or adalimumab-treated patients had a median reduction in serum alkaline phosphatase of 4% or 15%, respectively. Factors associated with lower serum alkaline phosphatase were normal values of this enzyme at baseline (P<0.01), treatment with adalimumab (P=0.090), and treatment in Europe (P=0.083). The study suggests that anti-TNF agents were moderately effective and were not associated with exacerbation of PSC symptoms or specific side-effects. The retrospective nature of the study and the small size of patients included are notable limitations. Sizable prospective studies are needed to further investigate the association between use of adalimumab and reduced serum levels of alkaline phosphatase as well as the clinical importance of this observation.

Read the paper from Dr. Hedin

Mon, Jan 20 9:44pm · Mayo Clinic launches Vancomycin clinical trial for Primary Sclerosing Cholangitis in Primary Sclerosing Cholangitis (PSC)

2019-01-14 PSC Clinical Trial

Mayo Clinic in Minnesota, Arizona and Florida is currently conducting a randomized placebo controlled clinical trial, examining the impact of oral vancomycin on markers of cholestasis among patients with PSC. The treatment period is approximately 18 months and requires about five clinic visits along with lab draws at home.

Please contact Mr. Mitch Clayton (study coordinator) at 507-284-2698 or clayton.mitchell@mayo.edu for additional details.

A link to the study on clinicaltrials.gov is provided below:

https://bit.ly/2RjImYP 

Dec 30, 2019 · Liver Stiffness is Associated with PSC Outcomes in Primary Sclerosing Cholangitis (PSC)

20919-01-31 Liver Elastography
In a recent paper, published in the Journal Clinical Gastroenterology and Hepatology, Eaton et al., found that measuring liver stiffness of patients suffering from PSC is associated with outcomes of the disease. “Monitoring liver stiffness with magnetic resonance elastography has prognostic value. Both baseline liver stiffness and changes in liver stiffness over time are associated with hepatic decompensation (i.e., failure of the liver). However, changes in liver stiffness are typically slow to occur unless advanced fibrosis is already present” Dr. Eaton said. This is the largest study of magnetic resonance elastography on PSC patients and introduces the utility of such non-invasive testing in future clinical trials of these patients.
Read the paper  from Dr. Eaton

Dec 16, 2019 · Statin Use and PSC in Primary Sclerosing Cholangitis (PSC)

2019-01-21 Statins PSC
In a recent paper published in the journal Clinical Gastroenterology and Hepatology,  Stokkeland K. et al., reported the effects of exposure to medications on the outcomes of PSC using a population-based cohort of 2,914 patients from Sweden. The authors found that use of statins or azathioprine, among patients with PSC, was associated with reduced risk of all cause mortality, death or liver transplantation. Of note, exposure to ursodeoxycholic acid did not affect the mortality of these patients. Despite the retrospective nature of this study, these interesting findings suggest pursuing further investigation on the role of statins in the outcomes of PSC.

Dec 2, 2019 · Coping Needs of Children with Primary Sclerosing Cholangitis in Primary Sclerosing Cholangitis (PSC)

2019-01-14 PSC Child

Primary Sclerosing Cholangitis (PSC) is a slowly progressing disease that affects both adults and children. Several of the clinical features of the disease are different between pediatric and adult patients. Importantly, the coping elements of the disease in children and their families are unique.

In this presentation, Dr. Mounif El-Youssef, an Associate Professor of Medicine and a Pediatric Hepatologist from Mayo Clinic, discusses the coping needs of a child diagnosed with PSC.

View the full presentation from Dr. El-Youssef.

Nov 18, 2019 · An Overview of Primary Sclerosing Cholangitis in Primary Sclerosing Cholangitis (PSC)

2019-01-16 PSC Liver

Primary Sclerosing Cholangitis (PSC) is a rare, chronic liver disease that affects about 1 in 10,000 people.

In this presentation, Robert C. Huebert, M.D, an Associate Professor of Medicine and transplant Hepatologist from Mayo Clinic, provides a great overview of PSC, including promising approaches of regenerative medicine to treat the disease.

View the full presentation from Dr. Huebert.