Evidence map›Paper›PMID 28833331›Full record

Trial reportHepatology (Baltimore, Md.)2018

A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis.

Scott L Friedman, Vlad Ratziu, Stephen A Harrison, Manal F Abdelmalek, Guruprasad P Aithal, Juan Caballeria, Sven Francque, Geoffrey Farrell, Kris V Kowdley, Antonio Craxi and 13 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 362 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
362citing papers in PubMed, 6 pooled it
55.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

362 citing papers in PubMed, 6 syntheses or guidelines pooled it, 647 citations in OpenAlex.

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  9. MAFLD/MASLD: Past, Present, and Future.Journal of gastroenterology and hepatology · 2026
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302 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors at 15 institutions in 10 countries.

Scott L FriedmanDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, Mount Sinai, NY.
Vlad RatziuPitié Salpêtrière Hospital and Pierre and Marie Curie University, Paris, France.
Stephen A HarrisonPinnacle Clinical Research, San Antonio, TX.
Manal F AbdelmalekDivision of Gastroenterology & Hepatology, Department of Medicine, Duke University, Durham, NC.
Guruprasad P AithalNottingham Digestive Diseases Centre National Institute for Health Research (NIHR) and Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK.
Juan CaballeriaLiver Unit, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigación en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain.
Sven FrancqueGastroenterology and Hepatology, Antwerp University Hospital, University of Antwerp, Antwerp, Belgium.
Geoffrey FarrellLiver Research Group, Australian National University Medical School at the Canberra Hospital, Canberra, Australian Capital Territory, Australia.
Kris V KowdleyLiver Care Network, Swedish Medical Center, Seattle, WA.
Antonio CraxiDepartment of Gastroenterology, DiBiMIS, University of Palermo, Palermo, Italy.
Krzysztof SimonDivision of Infectious Diseases and Hepatology, Faculty of Medicine and Dentistry, Wrocław Medical University, Wrocław, Poland.
Laurent FischerAllergan, Plc, South San Francisco, CA.
Liza Melchor-KhanAllergan, Plc, South San Francisco, CA.
Jeffrey VestMedpace, Inc., Cincinnati, OH.
Brian L WiensAllergan, Plc, South San Francisco, CA.
Pamela VigAllergan, Plc, South San Francisco, CA.
Star SeyedkazemiAllergan, Plc, South San Francisco, CA.
Zachary GoodmanCenter for Liver Diseases, Inova Fairfax Medical Campus, Falls Church, VA.
Vincent Wai-Sun WongDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.
Rohit LoombaDivision of Gastroenterology, Department of Medicine, University of California at San Diego, La Jolla, CA.
Frank TackeDepartment of Medicine III, University Hospital Aachen, Aachen, Germany.ORCID 0000-0001-6206-0226
Arun SanyalDepartment of Gastroenterology, Virginia Commonwealth University, Richmond, VA.
Eric LefebvreAllergan, Plc, South San Francisco, CA.
Pinnacle Clinical Research · USAustralian National University · AUNottingham University Hospitals NHS Trust · GBCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESChinese University of Hong Kong · HKDuke University · USIcahn School of Medicine at Mount Sinai · USMedpace (United States) · USSorbonne Université · FRSwedish Medical Center · USUniversitätsklinikum Aachen · DEUniversity of Antwerp · BEUniversity of Palermo · ITVirginia Commonwealth University · USWroclaw Medical University · PL

Funding

Translational Research CoreP30DK020541 · NIDDK · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI STREAMSON C CHUA · 2015 to 2026
$27.7M
Medical Research Council MR/N005953/1NIDDK NIH HHS P30 DK020541
6 · The paper itself

Abstract

The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of CC chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis (LF). A randomized, double-blind, multinational phase 2b study enrolled subjects with NASH, a nonalcoholic fatty liver disease activity score (NAS) ≥4, and LF (stages 1-3, NASH Clinical Research Network) at 81 clinical sites. Subjects (N = 289) were randomly assigned CVC 150 mg or placebo. Primary outcome was ≥2-point improvement in NAS and no worsening of fibrosis at year 1. Key secondary outcomes were: resolution of steatohepatitis (SH) and no worsening of fibrosis; improvement in fibrosis by ≥1 stage and no worsening of SH. Biomarkers of inflammation and adverse events were assessed. Full study recruitment was achieved. The primary endpoint of NAS improvement in the intent-to-treat population and resolution of SH was achieved in a similar proportion of subjects on CVC (N = 145) and placebo (N = 144; 16% vs. 19%, P = 0.52 and 8% vs. 6%, P = 0.49, respectively). However, the fibrosis endpoint was met in significantly more subjects on CVC than placebo (20% vs. 10%; P = 0.02). Treatment benefits were greater in those with higher disease activity and fibrosis stage at baseline. Biomarkers of systemic inflammation were reduced with CVC. Safety and tolerability of CVC were comparable to placebo.

conclusionAfter 1 year of CVC treatment, twice as many subjects achieved improvement in fibrosis and no worsening of SH compared with placebo. Given the urgent need to develop antifibrotic therapies in NASH, these findings warrant phase 3 evaluation. (Hepatology 2018;67:1754-1767).

Indexed as

AdultAgedBiomarkersCCR5 Receptor AntagonistsDouble-Blind MethodFemaleHumansImidazolesLiverLiver CirrhosisMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseSulfoxidesTreatment OutcomeBiomarkersCCR5 Receptor AntagonistscenicrivirocImidazolesSulfoxides

Identifiers

PMID28833331
PMCPMC5947654
OpenAlexW2746863374

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.