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NCT03710122
Vancomycin for Primary Sclerosing Cholangitis
Phase 2, PHASE3 trial testing Vancomycin in Primary Sclerosing Cholangitis in 102 participants. Completed in 20 March 2025.
3 March 2025
Quick facts
| Lead sponsor | Elizabeth Carey |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 23 January 2020 |
| Primary completion | 3 March 2025 |
| Estimated completion | 20 March 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Vancomycin (vancomycin) — full drug profile →
- Placebo
Conditions studied
- Primary Sclerosing Cholangitis — all drugs for Primary Sclerosing Cholangitis →
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):
-
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 -
The Gut-Liver Axis in Cholestatic Liver Diseases.
Blesl A, Stadlbauer V. · · 2021 · cited 58× · PMID 33801133 · DOI 10.3390/nu13031018 -
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 -
Primary sclerosing cholangitis.
Rabiee A, Silveira MG. · · 2021 · cited 40× · PMID 33824933 · DOI 10.21037/tgh-20-266 -
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 -
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 -
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 -
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:
- PubMed search for NCT03710122
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vancomycin
Trials testing the same drug.
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- NCT06567808 — Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial · Phase 4 · not yet recruiting
- NCT06702345 — Clostridioides Difficile Controlled Human Infection Model · NA · not yet recruiting
- NCT06716749 — Effectiveness of Adding Morphine to Intraosseous Vancomycin for Pain Control in Total Knee Arthroplasty · Phase 2 · completed
- NCT06439953 — Irrisept Solution for Instrumented Spine Surgery · NA · recruiting
Other recruiting trials for Primary Sclerosing Cholangitis
Currently open trials in the same condition.
- NCT07229911 — A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC) · Phase 1 · recruiting
- NCT06905054 — Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation · Phase 2 · recruiting
- NCT06455280 — A Study of SIPLIZUMAB in AILD and LT Patients · Phase 1 · recruiting
- NCT06519162 — Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome · recruiting
- NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis · NA · recruiting
Other Elizabeth Carey trials
Trials by the same sponsor.
- NCT03722576 — Vidofludimus Calcium for Primary Sclerosing Cholangitis · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03710122 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Elizabeth Carey
- Last refreshed: 22 August 2025
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