NCT03710122

Vancomycin for Primary Sclerosing Cholangitis

A Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing Cholangitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Elizabeth Carey · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Vancomycin	Firvanq by Azurity Pharmaceuticals, Inc.
OTHER	Placebo	Placebo for Vancomycin

Timeline

• Start date: 2020-01-23
• Primary completion: 2025-03-03
• Completion: 2025-03-20
• First posted: 2018-10-17
• Last updated: 2025-08-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study