Efficacy and Safety of Cenicriviroc in Patients With Primary Sclerosing Cholangitis: PERSEUS Study
| Autor: | Christopher L. Bowlus, Cynthia Levy, Aldo J. Montano-Loza, Eric Lefebvre, Eduardo B. Martins, Jawad Ahmad, Bertus Eksteen, Paul J. Pockros, Pamela Vig, Kidist K. Yimam, Jordan J. Feld, Gerald Y. Minuk, Laurent Fischer |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Canada medicine.medical_specialty Adolescent Cholangitis Cholangitis Sclerosing Inflammatory bowel disease Gastroenterology Sclerosing Primary sclerosing cholangitis Young Adult Rare Diseases Liver Function Tests Clinical Research Fibrosis Internal medicine medicine Clinical endpoint Humans lcsh:RC799-869 Adverse effect Aged Hepatology business.industry Surrogate endpoint Imidazoles Evaluation of treatments and therapeutic interventions Original Articles Middle Aged Alkaline Phosphatase medicine.disease Rash United States Treatment Outcome 6.1 Pharmaceuticals Sulfoxides lcsh:Diseases of the digestive system. Gastroenterology Original Article Female Patient Safety medicine.symptom business Body mass index Biomarkers |
| Zdroj: | Hepatology Communications Hepatology Communications, Vol 5, Iss 3, Pp 478-490 (2021) Hepatology communications, vol 5, iss 3 |
| ISSN: | 2471-254X |
| DOI: | 10.1002/hep4.1619 |
| Popis: | Primary sclerosing cholangitis (PSC) is a chronic cholestatic disease with no approved treatments. C-C chemokine receptor types 2 and 5 (CCR2/CCR5) play an important role in inflammation and fibrosis and are potential therapeutic targets for PSC. We evaluated the efficacy and safety of cenicriviroc (CVC), a dual antagonist of CCR2 and CCR5, for the treatment of PSC. This was a single-arm, open-label, exploratory study of CVC in adults with a clinical diagnosis of PSC, serum alkaline phosphatase (ALP) ≥1.5 times the upper limit of normal (ULN), with or without inflammatory bowel disease, across eight sites in the United States and Canada. The primary endpoint was percent change in ALP over 24 weeks; key secondary efficacy endpoints were proportion of participants who achieved ALP normalization and overall response (decrease to |
| Databáze: | OpenAIRE |
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