Fibrosis as an end point for clinical trials in liver disease: a report of the international fibrosis group.
Deaths due to the consequences of advanced liver fibrosis and cirrhosis remain a significant cause of mortality worldwide. Biologically plausible pathways involved in hepatic fibrogenesis have also led to the identification of numerous preclinical and clinical compounds that have received great interest as potential future therapeutic agents for patients with liver fibrosis. With this in mind, stake holders from academia, regulatory agencies, clinicians, and the pharmaceutical industry met to understand and discuss the many complex issues involved in developing potential therapeutic agents which act primarily through modifying fibrosis and to discuss appropriate end points for clinical trials in these patient populations. In this article, we summarize those discussions and attempt to highlight many of the hurdles and unanswered questions as we attempt to move forward and develop therapies to combat liver fibrosis.
McHutchison
John
J
GI/Hepatology Research, Duke Clinical Research Institute, Durham, North Carolina 27707, USA. mchut001@mc.duke.edu
Poynard
Thierry
T
Afdhal
Nezam
N
D000818:Animals; D000998:Antiviral Agents / Q000627:therapeutic use*; D001706:Biopsy; D002986:Clinical Trials as Topic / Q000379:methods*; D018450:Disease Progression; D006801:Humans; D007371:Interferon-gamma / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
D000998:Antiviral Agents; D007371:Interferon-gamma