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Trial record 5 of 92 for:    Primary Sclerosing Cholangitis

Vancomycin for Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT03710122
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Arizona State University
Information provided by (Responsible Party):
Elizabeth Carey, Mayo Clinic

Brief Summary:

To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis.

Funding Source - FDA OOPD


Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Vancomycin Other: Placebo Phase 2 Phase 3

Detailed Description:

A. Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6,12,and 18 months of OV treatment, and at 3, and 6 months post OV treatment will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.

B. Determine if OV stabilizes or improves liver fibrosis assessed by LSM using TE. Liver stiffness will be measured at 6, 12, and 18 months of OV treatment, and at 6 months post OV treatment, and values will be compared to those obtained at baseline (month 0), and with values in the placebo arm.

C. Determine the changes in the intestinal microbiota in relation to the use of OV, and study the correlation between the changes in the intestinal microbiota and the changes in: 1) liver enzymes, particularly serum ALP, and 2) liver stiffness, assessed by LSM using TE.

D. Determine if changes in proinflammatory cytokines (TGF-β, IL-4, IL-13, IL-10, etc.) predict response to OV. Cytokines will be measured at baseline, months 6, 12, 18, and at 3, and 6 months post OV treatment, if the study is positive.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing Cholangitis
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Experimental: Vancomycin Drug: Vancomycin
Firvanq by Cutis Pharma

Placebo Comparator: Placebo Other: Placebo
Placebo for Vancomycin




Primary Outcome Measures :
  1. Alkaline phosphatase at 6 months [ Time Frame: 6 months ]
    Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.

  2. Alkaline phosphatase at 12 months [ Time Frame: 12 months ]
    Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 12 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.

  3. Alkaline phosphatase at 18 months [ Time Frame: 18 months ]
    Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 18 months of OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.

  4. Alkaline phosphatase at 3 months post treatment = 21 months [ Time Frame: 21 months ]
    Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 3 months post OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.

  5. Alkaline phosphatase at 6 months post treatment = 24 months [ Time Frame: 24 months ]
    Determine if OV normalizes serum ALP in adults with PSC. Levels of serum ALP obtained at 6 months post OV treatment, and will be compared to those obtained at baseline (month 0), and with values at the same study time points in the placebo arm.


Secondary Outcome Measures :
  1. Fibroscan, cholangiography [ Time Frame: 18 months ]
    Transient elastography (TE), a new technique that allows non-invasive assessment and follow up of liver fibrosis by measuring liver stiffness, differentiates between severe from non-severe fibrosis in PSC, and the rate of progression of liver stiffness measurement (LSM) assessed by TE correlates well with the rate of progression of fibrosis in PSC and with patients' clinical outcomes.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subject age 18-75 years
  2. 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.
  3. An ultrasound (or equivalent imaging modality) that excludes biliary obstruction and malignancy within 6 months of study entry.
  4. If a patient is on any of the following medications and/or supplements, he or she is expected to remain on the same daily dose through the treatment period: UDCA, azathioprine, prednisone (or an equivalent steroid compound), methotrexate, a 5-aminosalicylic acid, biologic therapy, and/or a probiotic.
  5. PSC with or without inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.
  6. Must agree to comply with the study protocol and provide informed consent.

Exclusion Criteria:

1. Administration of an antibiotic within 3 months prior to the study 2. Pregnancy or attempting to become pregnant or breastfeeding 3. Presence of any of the following:

  1. Hepatitis B infection
  2. Hepatitis C infection (antibody positive); patients with a history of hepatitis C infection will be eligible for this study if they have undetectable levels of HCV RNA
  3. Other cholestatic liver diseases such as primary biliary cholangitis and cholestatic diseases of pregnancy
  4. Metabolic liver diseases such as Wilson's disease and hemochromatosis
  5. Inherited diseases of the liver such as α-1 antitrypsin deficiency
  6. Immunoglobulin G4-related cholangitis
  7. PSC with concomitant autoimmune hepatitis (AIH) &/or primary biliary cholangitis (previously known as primary biliary cirrhosis)
  8. Secondary sclerosing cholangitis (SSC)
  9. Active acute ascending cholangitis requiring antibiotics
  10. CCA (malignant biliary stricture, neoplasm, & cytology/histopathology or positive fluorescence in situ hybridization (FISH) consistent with adenocarcinoma of the bile duct)
  11. A liver biopsy, if one has been previously obtained, which showed non-alcoholic steatohepatitis (NASH). Patients with suspected fatty liver imaging will not be excluded
  12. Presence of complications of advanced PSC such as hepatic encephalopathy, portal hypertension, hepato-renal syndrome and hepato-pulmonary syndrome
  13. History of liver transplantation, anticipated need for liver transplantation within 12 months from randomization, or a Model of End Stage Liver Disease (MELD) score of ≥15
  14. Ongoing alcohol abuse (>4 drinks per day for men, and >2 drinks per day for women)
  15. History of allergic reaction to vancomycin
  16. Moderate-to-severe renal impairment with a calculated creatinine clearance of <60mL/min

r. HIV/AIDS q. Any other conditions or abnormalities that, in that opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710122


Contacts
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Contact: Travis Johnson 408-342-2942 Johnson.Travis2@mayo.edu

Locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85259
Contact: Elizabeth Carey, MD    480-342-1094      
Arizona State University Active, not recruiting
Tempe, Arizona, United States, 85281
United States, Florida
Mayo Clinic Florida Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Denise M Harnois, DO    904-956-3258      
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: John Eaton, MD    507-284-3917      
Sponsors and Collaborators
Elizabeth Carey
Arizona State University
Investigators
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Principal Investigator: Elizabeth Carey, MD Mayo Clinic

Additional Information:
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Responsible Party: Elizabeth Carey, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03710122     History of Changes
Other Study ID Numbers: IND133287
FD-R-6102 ( Other Grant/Funding Number: FDA OOPD )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents