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Safety, tolerability, and efficacy of maralixibat in adults with primary sclerosing cholangitis: Open-label pilot study.

Christopher L BowlusBertus EksteenAngela C CheungDouglas ThorburnCynthia A MoylanPaul J PockrosLisa M FormanAlejandro DorenbaumGideon M HirschfieldCiara KennedyThomas JaecklinAndrew McKibbenElaine ChienMarshall BaekPamela VigCynthia Levy
Published in: Hepatology communications (2023)
Maralixibat was associated with reduced sBA levels in adults with PSC. In participants with more severe baseline pruritus, pruritus improved significantly from baseline. TEAEs were mostly gastrointestinal related. These results support further investigation of IBAT inhibitors for adults with PSC-associated pruritus. ClinicalTrials.gov: NCT02061540.
Keyphrases
  • early onset
  • open label
  • atopic dermatitis
  • clinical trial
  • phase ii
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  • phase iii
  • study protocol
  • randomized controlled trial
  • squamous cell carcinoma
  • radiation therapy
  • drug induced