Status:
TERMINATED
An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis
Lead Sponsor:
Yale University
Conditions:
Cholangitis, Sclerosing
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- Males and females ages 18-80
- Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without alternative explanation for findings, for at least 6 months.
- Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6 months.
- Ursodeoxycholic acid therapy must be discontinued for at least 3 months.
- At least 2 forms of barrier protection for males and females of child-bearing age.
Exclusion
- Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary sclerosing cholangitis.
- Any malignancy, presently or within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.
- Viral hepatitis including hepatitis A, B, C, D, E.
- Decompensated cirrhosis, or planned liver transplantation.
- Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within the past 3 months.
- Ascending Cholangitis requiring antibiotics within the past 3 months.
- Uncontrolled IBD, or IBD requiring the use of steroids.
- Acute or Chronic Kidney Disease with serum creatinine \> 2 mg/dL.
- Allergy to ATRA or vitamin A compounds.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03359174
Start Date
May 29 2018
End Date
January 1 2021
Last Update
August 9 2021
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06510