Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial

Therapie. 2012 Sep-Oct;67(5):423-7. doi: 10.2515/therapie/2012058. Epub 2012 Dec 18.

Abstract

Objective: To test the modulation of farnesoid X receptor activity on the replication of hepatitis C virus in chronically infected patients.

Methods: This is a proof-of-concept trial that was approved by the ex-French Agency for the Safety of Health Products (ex-Afssaps [currently ANSM]) and an ethics committee. It has started in January 2010. This one-arm, open-label study examines the safety and efficacy of the oral administration of guggulsterone. The main outcome measure will be the assessment of blood viral loads.

Results: We planned to enrol 15 genotype 1-infected patients that failed a first-line therapy.

Conclusion: We think guggulsterone might be an effective therapeutic option for HCV genotype 1 patients who do not respond well to first-line therapy.

Trial registration: ClinicalTrials.gov NCT01492998.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • Clinical Protocols*
  • Evidence-Based Practice
  • Hepatitis C / drug therapy*
  • Hepatitis C / virology
  • Humans
  • Male
  • Middle Aged
  • Molecular Targeted Therapy / methods*
  • Pilot Projects
  • Pregnenediones / administration & dosage
  • Pregnenediones / therapeutic use
  • Receptors, Cytoplasmic and Nuclear / antagonists & inhibitors*
  • Salvage Therapy
  • Viral Load / drug effects
  • Young Adult

Substances

  • Antiviral Agents
  • Pregnenediones
  • Receptors, Cytoplasmic and Nuclear
  • farnesoid X-activated receptor
  • pregna-4,17-diene-3,16-dione

Associated data

  • ClinicalTrials.gov/NCT01492998