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NCT03710122

Vancomycin for Primary Sclerosing Cholangitis

Completed Phase 2, PHASE3 Last updated 22 August 2025
What this trial tests

Phase 2, PHASE3 trial testing Vancomycin in Primary Sclerosing Cholangitis in 102 participants. Completed in 20 March 2025.

Timeline
23 January 2020
Primary endpoint
3 March 2025
20 March 2025

Quick facts

Lead sponsorElizabeth Carey
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment102
Start date23 January 2020
Primary completion3 March 2025
Estimated completion20 March 2025
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Elizabeth Carey — full company profile →

Who can join

Adults 18 to 76, any sex, with Primary Sclerosing Cholangitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Oral Vancomycin, Ursodeoxycholic Acid, or No Therapy for Pediatric Primary Sclerosing Cholangitis: A Matched Analysis.
    Deneau MR, Mack C, Mogul D, Perito ER, et al · · 2021 · cited 65× · PMID 32946600 · DOI 10.1002/hep.31560
  2. The Gut-Liver Axis in Cholestatic Liver Diseases.
    Blesl A, Stadlbauer V. · · 2021 · cited 58× · PMID 33801133 · DOI 10.3390/nu13031018
  3. Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: Current Knowledge of Pathogenesis and Therapeutics.
    Park JW, Kim JH, Kim SE, Jung JH, et al · · 2022 · cited 41× · PMID 35740310 · DOI 10.3390/biomedicines10061288
  4. Primary sclerosing cholangitis.
    Rabiee A, Silveira MG. · · 2021 · cited 40× · PMID 33824933 · DOI 10.21037/tgh-20-266
  5. Management of primary sclerosing cholangitis and its complications: an algorithmic approach.
    Prokopič M, Beuers U. · · 2021 · cited 30× · PMID 33377990 · DOI 10.1007/s12072-020-10118-x
  6. The Management of Cholestatic Liver Diseases: Current Therapies and Emerging New Possibilities.
    Mazzetti M, Marconi G, Mancinelli M, Benedetti A, et al · · 2021 · cited 17× · PMID 33919600 · DOI 10.3390/jcm10081763
  7. Role of intestinal flora in primary sclerosing cholangitis and its potential therapeutic value.
    Li ZJ, Gou HZ, Zhang YL, Song XJ, et al · · 2022 · cited 16× · PMID 36504550 · DOI 10.3748/wjg.v28.i44.6213
  8. Microbial Players in Primary Sclerosing Cholangitis: Current Evidence and Concepts.
    Özdirik B, Schnabl B. · · 2024 · cited 13× · PMID 38109970 · DOI 10.1016/j.jcmgh.2023.12.005

Verify or expand the search:

Other trials of Vancomycin

Trials testing the same drug.

Other recruiting trials for Primary Sclerosing Cholangitis

Currently open trials in the same condition.

Other Elizabeth Carey trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03710122.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing