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An Open-Label, Dose-Escalation Study to Assess the Safety and Efficacy of IL-22 Agonist F-652 in Patients With Alcohol-associated Hepatitis.

Juan Pablo ArabTejasav S SehrawatDouglas A SimonettoVikas K VermaDechun FengTom TangKevin DreyerXiaoqiang YanWilliam L DaleyArun SanyalNaga ChalasaniSvetlana RadaevaLiu YangHugo VargasMauricio IbacacheBin GaoGregory J GoresHarmeet MalhiPatrick S KamathVijay H Shah
Published in: Hepatology (Baltimore, Md.) (2020)
F-652 is safe in doses up to 45 μg/kg and associated with a high rate of improvement as determined by Lille and MELD scores, reductions in markers of inflammation and increases in markers of hepatic regeneration. This study supports the need for randomized placebo-controlled trials to test the efficacy of F-652 in AH.
Keyphrases
  • placebo controlled
  • double blind
  • stem cells
  • open label
  • oxidative stress
  • phase iii
  • randomized controlled trial
  • rectal cancer
  • phase ii study
  • alcohol consumption
  • locally advanced