A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction — Stella
Phase 1 — Early testing in a small group of people (usually 20–80) to evaluate safety, determine safe dosage, and identify side effects.
Trial locations(36 sites)
Germany
University Hospital Düsseldorf, Düsseldorf
University of Leipzig, Leipzig
Greece
Hippokration General Hospital of Athens, Athens
University Hospital of Patras, Pátrai
Hungary
Bekes County Central Hospital, Gyula
Facility of CRU Hungary Ltd., Kistarcsa
Italy
Università di Milano-Bicocca, S.C. ASST Grande Ospedale Metropolitano Niguarda, Dipartimento di Medicina e Chirurgia, Epatologia e Gastroenterologia, Milan
Fondazione IRCCS San Gerardo dei Tintori, Autoimmune Liver Disease Centre, ERN-Rare Liver, Department of Medicine and Surgery, Division of Gastroenterology, Monza
University of Padova, Department of Surgery, Oncology and Gastroenterology, Padova
University Hospital Paolo Giaccone, University of Palermo, Palermo
A. Gemelli Polyclinic, Sacro Cuore Catholic University, Roma
Humanitas University, Rozzano
University of Udine, Udine
Serbia
University Medical Center "Zvezdara", Belgrade
Spain
Hospital Universitario Parc Taulí, Barcelona
Hospital Clinic Barcelona, Barcelona
Hospital General Universitario Gregorio Marañón, Madrid
Hospital 12th October, Madrid, Madrid
Hospital Universitario Virgen De La Victoria, Málaga
University Hospital Complex of Pontevedra & IIS Galicia South, Pontevedra, Pontevedra
University Hospital Marquez de Valdecilla, Santander, Santander
Virgen del Rocio University Hospital, Seville
Hospital Universitario y Politécnico La Fe, Valencia
Turkey (Türkiye)
Hacettepe University, Fakulty of Medicine, Department of Gastroenterology and Hepatology, Ankara
Dicle University Faculty of Medicine Department of Gastroenterology, Diyarbakır
Ege University Faculty of Medicine, Department of Gastroenterology, Izmir
Kocaeli University Faculty of Medicine Gastroenterology and Hepatology Department, Kocaeli
United Kingdom
NIHR Birmingham BRC, Birmingham
Glasgow Royal Infirmary, Glasgow
Royal Free London NHS Foundation Trust, London
Guy's and St Thomas' Hospital, London, London
Freeman Hospital, Newcastle
Nottingham Digestive Diseases Centre and Biomedical Research Centre Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Nottingham
Oxford University Hospitals NHS Foundation Trust, Oxford
Dept of Gastroenterology & Hepatology Portsmouth Hospitals University NHS Trust Queen Alexandra Hospital, Portsmouth
Royal Wolverhampton NHS Trust, New Cross Hospital, Wolverhampton