Evidence map›Paper›PMID 24500662›Full record

ArticleCPT: pharmacometrics & systems pharmacology2014

A mechanistic model of drug-induced liver injury AIDS the interpretation of elevated liver transaminase levels in a phase I clinical trial.

B A Howell, S Q Siler, L K M Shoda, Y Yang, J L Woodhead, P B Watkins

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03063736 (Entolimod, an Adjuvant for Vaccine Augmentation), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT03063736 early_phase1completednot on this mapstarted 2017, after this paper: background citation

Entolimod, an Adjuvant for Vaccine Augmentation

TypeinterventionalSponsorBaylor College of MedicineRan2017 to 2019Enrolled40ConditionsSubstance Use DisordersArmsEntolimod, Td Vaccine
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
  2. Radiomitigators: Breakthroughs in Post-Radiation Recovery.Antioxidants (Basel, Switzerland) · 2026
    Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. The transformation in biomarker detection and management of drug-induced liver injury.Liver international : official journal of the International Association for the Study of the Liver · 2017
    Review
  11. Synergistic hepatoprotective potential of ethanolic extract ofJournal of traditional and complementary medicine · 2016
    Article
  12. Impact of Propionic Acid on Liver Damage in Rats.International journal of molecular and cellular medicine · 2015
    Article
  13. Article
  14. Article
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

6 authors.

B A HowellThe Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, North Carolina, USA.
S Q SilerThe Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, North Carolina, USA.
L K M ShodaThe Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, North Carolina, USA.
Y YangThe Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, North Carolina, USA.
J L WoodheadThe Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, North Carolina, USA.
P B Watkins1] The Hamner-UNC Institute for Drug Safety Sciences, The Hamner Institutes, Research Triangle Park, North Carolina, USA [2] School of Medicine and School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Entolimod (CBLB502) is a Toll-like receptor 5 agonist in development as a single-dose countermeasure against total body irradiation. Efficacy can be assessed from animal studies, but the "Animal Rule" does not apply to safety assessment. Marked elevations of serum aminotransferases (exceeding 1,000 IU/l) were observed in some human subjects receiving Entolimod in a safety study, threatening its continued development. The percentage of total hepatocytes undergoing necrosis in these subjects was estimated using a mechanistic, multiscale, mathematical model (DILIsym). The simulations suggested that no subject in the safety study experienced more than a modest loss of hepatocytes (<5%), which was comparable to estimates from a study of healthy volunteers receiving treatment with heparins. The predicted hepatocyte loss with Entolimod was lower than that required to cause liver dysfunction or that is routinely excised from volunteers donating for autologous liver transplantation and did not likely represent a serious health risk.

Identifiers

PMID24500662
PMCPMC3944113

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Registered trials

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.