Safety and disease monitoring biomarkers in Duchenne muscular dystrophy: results from a Phase II trial
| Autor: | Shashi K. Ramaiah, Kathryn R. Wagner, Francesco Muntoni, M. Guglieri, Lawrence Charnas, Vishal S. Vaidya, Richard Goldstein, Shannon Marraffino, Michael Binks, Jeffrey P. Palmer |
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| Rok vydání: | 2021 |
| Předmět: |
Oncology
Male medicine.medical_specialty Adolescent Duchenne muscular dystrophy Clinical Biochemistry Antibodies Monoclonal Humanized Sensitivity and Specificity Double-Blind Method Glutamate Dehydrogenase Internal medicine Drug Discovery medicine Humans In patient Aspartate Aminotransferases Child Creatine Kinase Liver injury biology Dose-Response Relationship Drug business.industry Glutamate dehydrogenase Biochemistry (medical) Troponin I Alanine Transaminase Disease monitoring medicine.disease Clinical trial Muscular Dystrophy Duchenne Treatment Outcome biology.protein Biomarker (medicine) Creatine kinase Drug Monitoring business Biomarkers |
| Zdroj: | Biomarkers in medicine. 15(15) |
| ISSN: | 1752-0371 |
| Popis: | Aim: Evaluate the utility of glutamate dehydrogenase (GLDH) and cardiac troponin I as safety biomarkers, and creatine kinase and muscle injury panel as muscle health biomarkers in Duchenne muscular dystrophy. Patients & methods: Data were collected during a Phase II trial of domagrozumab. Results: GLDH was a more specific biomarker for liver injury than alanine aminotransferase. Cardiac troponin I elevations were variable and not sustained, limiting its applicability as a biomarker. Muscle injury panel biomarkers were no more informative than creatine kinase as a muscle health biomarker. Conclusion: Results support the use of GLDH as a specific biomarker for liver injury in patients with Duchenne muscular dystrophy. Clinical trial registration: ClinicalTrials.gov , NCT02310763 . |
| Databáze: | OpenAIRE |
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