This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
oral suspension daily for 28 days
California Pacific Medical Center
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Southern Therapy and Advanced Research
Jackson, Mississippi, United States
Charlotte Mecklenburg Hospital
Charlotte, North Carolina, United States
Percent Change of Alkaline Phosphatase (ALP) From Baseline
Time frame: Day 28 (end of treatment) and Day 56 (end of study/early termination)
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
Liver enzymes include alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), bilirubin. Percent change from baseline through the end of study treatment (Day 28) and throughout the follow-up period (Day 56).
Time frame: Day 28 and Day 56
Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
Time frame: Day 28 (end of treatment) and Day 56 (end of follow-up)
Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.
Time frame: Day 28 and Day 56
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