American association for the study of liver diseases endpoints conference: Design and endpoints for clinical trials in primary biliary cirrhosis
✍ Scribed by Marina G. Silveira; Elizabeth M. Brunt; Jenny Heathcote; Gregory J. Gores; Keith D. Lindor; Marlyn J. Mayo
- Publisher
- John Wiley and Sons
- Year
- 2010
- Tongue
- English
- Weight
- 143 KB
- Volume
- 52
- Category
- Article
- ISSN
- 0270-9139
No coin nor oath required. For personal study only.
✦ Synopsis
A group of multidisciplinary experts on primary biliary cirrhosis (PBC) and its complications convened on May 31, 2009, under the aegis of the American Association for the Study of Liver Diseases (AASLD) in order to identify the most appropriate design and endpoints for clinical trials of PBC based on current evidence and expert experience. The natural history of PBC was reviewed as well as current therapies. The current approaches to evaluating therapies for disease progression and symptoms as priorities were discussed. Appropriate aspects of trial design including entry criteria, study duration, and appropriate handling of issues such as stratification of subjects and use of ursodeoxycholic acid (UDCA), were identified and discussed. After a full day of presentations, in a consensus manner, appropriate endpoints for clinical efficacy trials regarding PBC and its complications were agreed upon and are reported in this summary.