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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01802073 |
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Date of registration:
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21/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
PSC |
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Scientific title:
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Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01802073 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth Cox, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US
- Colonoscopy within 1 year or starting of study
- 2 groups:
1. IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD
2. No IBD and PSC, but positive p-ANCA or ASCA serologies indicating possible IBD.
Exclusion Criteria:
- Allergy to Vancomycin
- PSC not associated with IBD or NO positive IBD antibodies (p-ANCA [anti- neutrophil
cytoplasmic antibody] or ASCA [anti-Saccharomyces cerevisiae antibody])
- Cholangiocarcinoma
- On oral or topical (enemas or suppositories) corticosteroids,topical mesalamine, or
biologics (infliximab, adalimumab, certolizumab).
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Sclerosing Cholangitis
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Intervention(s)
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Drug: Oral Vancomycin
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Primary Outcome(s)
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Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1
[Time Frame: Baseline; Year 1]
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Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1
[Time Frame: Baseline; Year 1]
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Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3
[Time Frame: Baseline; Month 3]
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Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1
[Time Frame: Baseline; Year 1]
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Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3
[Time Frame: Baseline; Month 3]
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Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3
[Time Frame: Baseline; Month 3]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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