27
Participants
Start Date
October 31, 2010
Primary Completion Date
December 31, 2016
Study Completion Date
June 30, 2017
ursodeoxycholic acid (UDCA)
Pediatric PSC patients already receiving UDCA therapy will enter a four-phase trial consisting of baseline data collection (phase I, 4 weeks), 50% reduction in UDCA dose (phase II, 4 weeks), discontinuation of UDCA (phase III, 8 weeks) and reinstitution of therapy at a dose of 20 mg/kg/day (phase IV, 8 weeks). Surveillance and endpoint evaluation for each phase will include liver chemistries and clinical data. Comparisons will be made between baseline and the end of phase III (primary outcome) and between the end of phase III and the end of phase IV (secondary outcome). Serum cytokine biomarkers will be measured and compared between baseline and the end of phase III and between the end of phases III and IV.
University of Pittsburgh, Pittsburgh
Children's Hospital of Philadelphia, Philadelphia
Children's Healthcare of Atlanta, Emory University School of Medicine, Atlanta
University of Tennessee Health Science Center, Memphis
Northwestern University, Chicago
Texas Children's Hospital, Houston
Children's Hospital Colorado, Aurora
Phoenix Children's Hospital, Phoenix
Children's Hospital Los Angeles, Los Angeles
University of California, San Francisco, San Francisco
Yale New Haven Children's Hospital, New Haven
Mount Sinai School of Medicine, New York
Collaborators (1)
Icahn School of Medicine at Mount Sinai
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
University of Colorado, Denver
OTHER
University of California, San Francisco
OTHER
University of Pittsburgh
OTHER
Phoenix Children's Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
Children's Healthcare of Atlanta
OTHER
Children's Hospital Los Angeles
OTHER
Baylor College of Medicine
OTHER
Yale University
OTHER
University of Tennessee
OTHER