Evidence map›Paper›PMID 25626988›Full record

ReviewHepatology (Baltimore, Md.)2015

Strategies and endpoints of antifibrotic drug trials: Summary and recommendations from the AASLD Emerging Trends Conference, Chicago, June 2014.

Natalie J Torok, Jonathan A Dranoff, Detlef Schuppan, Scott L Friedman

Abstract readReview
In one paragraph

Review in Hepatology (Baltimore, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
–field-weighted citation impact
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

35 citing papers in PubMed.

  1. Simtuzumab treatment of advanced liver fibrosis in HIV and HCV-infected adults: results of a 6-month open-label safety trial.Liver international : official journal of the International Association for the Study of the Liver · 2016
    Trial
  2. Article
  3. Review
  4. Review
  5. Regression of hepatic fibrosis after pharmacological therapy for nonalcoholic steatohepatitis.World journal of gastrointestinal pharmacology and therapeutics · 2024
    Review
  6. Review
  7. Review
  8. Review
  9. Targeting the Wnt Signaling Pathway in Liver Fibrosis for Drug Options: An Update.Journal of clinical and translational hepatology · 2021
    Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Review
  18. [Consensus on the diagnosis and therapy of hepatic fibrosis in].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2019
    Article
  19. Article
  20. Review
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

4 authors.

Natalie J TorokDepartment of Gastroenterology and Hepatology, UC Davis Medical Center, Sacramento, CA and VA Northern California Healthcare System, Mather CA.
Jonathan A DranoffDivision of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, AR, and Research Service, Central Arkansas VA Healthcare System, Little Rock, AR.
Detlef SchuppanInstitute of Translational Immunology and Research Center for Immunotherapy, University Medical Center, Mainz, Germany.
Scott L FriedmanDivision of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY.

Funding

The Role of KLF6 in Hepatic FibrosisR01DK056621 · NIDDK · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI FRIEDMAN, SCOTT L. · 2000 to 2019
$6.2M
Autophagy during hepatic stellate cell activation in alcoholic liver injuryR01AA020709 · NIAAA · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI FRIEDMAN, SCOTT L. · 2011 to 2015
$1.8M
The Role of TNF alpha Converting Enzyme in Alcoholic Liver DiseaseI01BX002418 · VA · VETERANS ADMIN PALO ALTO HEALTH CARE SYS · PI Natalie J. Torok · 2014 to 2026
–
BLRD VA I01 BX002418NIAAA NIH HHS R01 AA020709NIDDK NIH HHS R01 DK056621
6 · The paper itself

Abstract

There is an urgent need to develop antifibrotic therapies for chronic liver disease, and clarify which endpoints in antifibrotic trials will be acceptable to regulatory agencies. The American Association for the Study of Liver Diseases sponsored an endpoints conference to help accelerate the efficient testing of antifibrotic agents and develop recommendations on clinical trial design for liver fibrosis. In this review, we summarize the salient and novel elements of this conference and provide directions for future clinical trial design. The article follows the structure of the conference and is organized into five areas: (1) antifibrotic trial design; (2) preclinical proof-of-concept studies; (3) pharmacological targets, including rationale and lessons to learn; (4) rational drug design and development; and (5) consensus and recommendations on design of clinical trials in liver fibrosis. Expert overviews and collaborative discussions helped to summarize the key unmet needs and directions for the future, including: (1) greater clarification of at-risk populations and study groups; (2) standardization of all elements of drug discovery and testing; (3) standardization of clinical trial approaches; (4) accelerated development of improved noninvasive markers; and (5) need for exploration of potential off-target toxicities of future antifibrotic drugs.

Indexed as

Clinical Trials as TopicChicagoCongresses as TopicDrug DesignFemaleHumansLiver CirrhosisMalePractice Guidelines as TopicPrescription DrugsUnited StatesUnited States Food and Drug AdministrationPrescription Drugs

Identifiers

PMID25626988
PMCPMC4515973

What OpenQuestion holds

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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.