Cited by 298Liver Diseases and ImmunityInflammatory Bowel DiseasePediatric Hepatobiliary Diseases and Treatments

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norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis

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Fickert, Peter, Hirschfield, Gideon M., Denk, Gerald, Marschall, Hanns-Ulrich, Altorjay, Istvan, Färkkilä, Martti, Schramm, Christoph, Spengler, Ulrich, Chapman, Roger, Bergquist, Annika, Schrumpf, Erik, Nevens, Frederik, Trivedi, Palak, Reiter, Florian P., Tornai, Istvan, Halilbasic, Emina, Greinwald, Roland, Pröls, Markus, Manns, Michael P., Trauner, Michael·2017·Journal of Hepatology

DOI 10.1016/j.jhep.2017.05.009

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Abstract

BACKGROUND & AIM: homologue of UDCA and has shown potent anti-cholestatic, anti-inflammatory and anti-fibrotic properties in a preclinical PSC mouse model. A randomized controlled trial, including 38 centers from 12 European countries, evaluated the safety and efficacy of three doses of oral norUDCA (500mg/d, 1,000mg/d or 1,500mg/d) compared with placebo in patients with PSC. METHODS: One hundred sixty-one PSC patients without concomitant UDCA therapy and with elevated serum alkaline phosphatase (ALP) levels were randomized for a 12-week treatment followed by a 4-week follow-up. The primary efficacy endpoint was the mean relative change in ALP levels between baseline and end of treatment visit. RESULTS: norUDCA reduced ALP levels by -12.3%, -17.3%, and -26.0% in the 500, 1,000, and 1,500mg/d groups (p=0.029, p=0.003, and p<0.0001 when compared to placebo), respectively, while a +1.2% increase was observed in the placebo group. Similar dose-dependent results were found for secondary endpoints, such as ALT, AST, γ-GT, or the rate of patients achieving ALP levels <1.5× ULN. Serious adverse events occurred in seven patients in the 500mg/d, five patients in the 1,000mg/d, two patients in the 1500mg/d group, and three in the placebo group. There was no difference in reported pruritus between treatment and placebo groups. CONCLUSIONS: norUDCA significantly reduced ALP values dose-dependently in all treatment arms. The safety profile of norUDCA was excellent and comparable to placebo. Consequently, these results justify a phase III trial of norUDCA in PSC patients. Lay summary: Effective medical therapy for primary sclerosing cholangitis (PSC) is urgently needed. In this phase II clinical study in PSC patients, a side chain-shortened derivative of ursodeoxycholic acid, norursodeoxycholic acid (norUDCA), significantly reduced serum alkaline phosphatase levels in a dose-dependent manner during a 12-week treatment. Importantly, norUDCA showed a favorable safety profile, which was similar to placebo. The use of norUDCA in PSC patients is promising and will be further evaluated in a phase III clinical study. ClinicalTrials.gov number: NCT01755507.

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Authors: Fickert, P., Hirschfield, G. M., Denk, G., Marschall, H.-U., Altorjay, I., Färkkilä, M., Schramm, C., Spengler, U., Chapman, R., Bergquist, A., Schrumpf, E., Nevens, F., Trivedi, P., Reiter, F. P., Tornai, I., Halilbasic, E., Greinwald, R., Pröls, M., Manns, M. P., & Trauner, M.
Affiliations: Medical University of Graz (AT)
University of Birmingham (GB)
LMU Klinikum (DE)
University of Gothenburg (SE)
University of Helsinki (FI)
University Medical Center Hamburg-Eppendorf (DE)
University of Bonn (DE)
John Radcliffe Hospital (GB)
Karolinska University Hospital (SE)
Oslo University Hospital (NO)
KU Leuven (BE)
Medical University of Vienna (AT)
Dr Falk Pharma (Germany) (DE)
Medizinische Hochschule Hannover (DE)
Corresponding author: Trauner, Michael
ORCID: Fickert, Peter
Hirschfield, Gideon M.
Marschall, Hanns-Ulrich
Färkkilä, Martti
Schramm, Christoph
Spengler, Ulrich
Chapman, Roger
Bergquist, Annika
Nevens, Frederik
Trivedi, Palak
Reiter, Florian P.
Halilbasic, Emina
Manns, Michael P.
Trauner, Michael
Venue: Journal of Hepatology
Publisher: Elsevier BV
Published: 2017-09
Volume: 67
Issue: 3
Pages: 549-558
ISSN: 0168-8278 (ISSN-L)
DOI: 10.1016/j.jhep.2017.05.009
OpenAlex: W2616282068
Cited by: 297
References: 45
Citations by year: 2026: 30 · 2025: 22 · 2024: 38 · 2023: 25 · 2022: 35 · 2021: 43 · 2020: 36 · 2019: 29 · 2018: 28 · 2017: 9
FWCI: 17.19
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Journal of Hepatology (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Työväentutkimus Vuosikirja (submittedVersion)
Lirias (KU Leuven) (submittedVersion, cc-by-nc-nd)
University of Debrecen Electronic Archive (University of Debrecen) (submittedVersion, cc-by-nc-nd)
University of Birmingham Research Portal (University of Birmingham) (submittedVersion, cc-by-nc-nd)
Funders: Falk Foundation
Pfizer
Gilead Sciences
National Institute for Health and Care Research
Astellas Pharma
Dr. Falk Pharma
Cilag
Topics: Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
Health Sciences › Medicine › Gastroenterology › Inflammatory Bowel Disease
Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
Keywords: primary sclerosing cholangitis, cholestasis, alkaline phosphatase, dose-dependent effects, safety profile, pruritus, liver fibrosis
MeSH terms: Adult, Alkaline Phosphatase, Cholestasis, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Ursodeoxycholic Acid, Cholangitis, Sclerosing

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