The purpose of this research study is to determine whether a low dose of ATRA will improve laboratory tests of liver and bile duct inflammation in patients with PSC. The investigators will also look for changes to other blood tests which are related to inflammation, scarring, and the immune system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Fixed low dose of ATRA 10 mg twice daily for 24 weeks.
Yale University
New Haven, Connecticut, United States
Change of Serum Alkaline Phosphatase (ALP)
Blood will be drawn at each time point to compare pre- and post-treatment values for each individual.
Time frame: Baseline to week 24.
Change in Patients Who Have Normalization of Serum ALP or Reduction to Less Than 1.5 x Upper Limit of Normal (ULN)
Blood is drawn at each time point to assess the outcome.
Time frame: Baseline to week 24.
The Percent of Patients Who Have Reduction of Serum C4 by 50%
Blood is drawn at each time point to assess the outcome.
Time frame: Baseline to week 24.
The Percent of Patients Who Have Reduction of Serum Bile Acids by 50%
Blood is drawn at each time point to assess the outcome.
Time frame: Baseline to week 24.
The Percent of Patients Who Have Reduction of Serum Alanine Aminotransferase (ALT) by 50%
Blood is drawn at each time point to assess the outcome.
Time frame: Baseline to week 24.
The Percent of Patients Who Have Reduction of Serum Enhanced Liver Fibrosis Score (ELF) by 10%
Blood is drawn at each time point to assess the outcome.
Time frame: Baseline to week 24.
The Percent of Patients Who Have Improvement in Fibrosis Per Transient Elastography by at Least 1 Stage
Transient Elastography will be performed at baseline and week 24 to assess the outcome.
Time frame: Baseline to week 24.
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