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Title
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Phase 2, open-label, rollover study of cenicriviroc for liver fibrosis associated with metabolic dysfunction-associated steatohepatitis
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Author
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Abstract
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| Background: Cenicriviroc (CVC) is a novel, orally administered antagonist of chemokine receptor types 2/5 that has demonstrated antifibrotic activity in a phase 2b study of patients with NASH. This phase 2, open -label, rollover study investigated the long-term safety and tolerability of CVC in patients with NASH and stage 0-4 liver fibrosis. Methods: Eligible patients who completed the phase 2 CENTAUR study or reached a predefined endpoint in the phase 3 AURORA study were rolled over and received open -label CVC 150 mg once daily. Safety assessments were conducted at the start of the study, and patients were seen in the clinic every 3 months until the study sponsor terminated CVC development. Safety endpoints included treatment -emergent adverse events (TEAEs), treatmentrelated TEAEs, adverse event severity, and clinical laboratory assessments. Results: A total of 167 patients were enrolled, with a median treatment duration of 33.6 months. Before study termination, 36 patients (21.6%) prematurely discontinued the study. Treatment -related TEAEs were reported in 28 patients (16.8%). The most common treatment -related TEAEs were 4 cases of diarrhea (2.4%) and 2 cases each (1.2%) of abdominal pain, nausea, alanine aminotransferase increased, aspartate aminotransferase increased, hypertriglyceridemia, myalgia, pruritus, and rash. The majority of these treatment -related events were mild in intensity, and none were life -threatening. There were no clinically meaningful changes in hepatic function, chemistry, or liver parameters from baseline to the end of the study. Conclusions: In this rollover study, CVC 150 mg once daily was well tolerated in patients with NASH and stage 0-4 liver fibrosis. No new safety signals were reported, and these data further support the safety and tolerability of CVC. |
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Language
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English
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Source (journal)
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Hepatology Communications / American Association for the Study of Liver Diseases
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Publication
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Wiley
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2024
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ISSN
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2471-254X
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DOI
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10.1097/HC9.0000000000000335
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Volume/pages
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8
:2
(2024)
, p. 1-8
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Article Reference
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e0335
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ISI
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001153188100001
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Pubmed ID
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38285756
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Full text (Publisher's DOI)
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Full text (open access)
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