Surrogate endpoints for clinical trials in primary sclerosing cholangitis: Review and results from an International PSC Study Group consensus process

Primary sclerosing cholangitis (PSC) is a rare, but serious, cholestatic disease for which, to date, no effective therapy exists to halt disease progression toward end‐stage liver disease. Clinical trial design to study drugs that improve prognosis is hampered by the relatively low event rate of cli...

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Veröffentlicht in:	Hepatology (Baltimore, Md.) Md.), 2016-04, Vol.63 (4), p.1357-1367
Hauptverfasser:	Ponsioen, Cyriel Y., Chapman, Roger W., Chazouillères, Olivier, Hirschfield, Gideon M., Karlsen, Tom H., Lohse, Ansgar W., Pinzani, Massimo, Schrumpf, Erik, Trauner, Michael, Gores, Gregory J.
Format:	Artikel
Sprache:	eng
Schlagworte:	Alkaline phosphatase Bilirubin Biomarkers - metabolism Cholangitis Cholangitis, Sclerosing - mortality Cholangitis, Sclerosing - pathology Cholangitis, Sclerosing - therapy Clinical trials Clinical Trials, Phase II as Topic Clinical Trials, Phase III as Topic Consensus Disease Progression Drug development End Stage Liver Disease - mortality End Stage Liver Disease - physiopathology End Stage Liver Disease - surgery Evidence-Based Medicine Female Hepatology Histology Humans Internationality Liver Liver diseases Liver Transplantation - methods Male Needs Assessment Practice Guidelines as Topic Rare Diseases Risk Assessment Survival Rate Transplants & implants Treatment Outcome
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