Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a multicenter, randomized, double-blinded placebo controlled trial to assess the
benefit of sulfasalazine in the treatment of PSC. The specific objectives of this study are
to determine if sulfasalazine treatment 1) results in reduced serum ALP and other biomarkers
of liver injury in PSC; 2) improves PSC patient symptoms; and 3) is safe in patients with
PSC.
Phase
Phase 2
Funding Agency/Sponsor
Other
Disease
Hepatitis B
Enrollment Eligibility
Inclusion Criteria:
1. Age 15-80
2. A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP)
demonstrating intrahepatic and/or extrahepatic biliary strictures, beading or
irregularity consistent with PSC.
3. ALP > 1.67 times the upper limit of normal (ULN) at screening
4. Inflammatory bowel disease
5. Subject must either be on a stable dose of ursodeoxycholic acid for > 6 months prior
to screening or have been discontinued > 4 weeks prior to screening (enrollment of
patients who are on UDCA will be limited to 50% of all enrolled patients).
Exclusion Criteria:
1. Anticipated need for liver transplant within one year as determined by Mayo PSC risk
score treatment
2. Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic
encephalopathy.
3. Evidence of advanced liver disease including MELD score > 10, bilirubin > 3.0,
platelet count < 100,000; or INR > 1.4
4. Concomitant chronic liver disease including alcohol related liver disease, chronic
hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin
deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary
cholangitis
5. Secondary causes of sclerosing cholangitis
6. Known intolerance to sulfasalazine (including but not limited to allergy to sulfa or
mesalamine) or folic acid
7. History of cholangiocarcinoma or colon cancer within 5 years
8. History of colectomy with > 1/3 bowel resected
9. Treatment with any investigational agents, within two months or 5 half-lives of the
investigational product, whichever is longer.
10. Active illicit drug or alcohol abuse
11. Current or past use of sulfasalazine within 6 months of enrollment.
12. Need for chronic use of antibiotics
13. Evidence of bacterial cholangitis within 6 months of enrollment
14. In patients with Ulcerative Colitis, simple clinical colitis activity index of > 4 or,
if Crohn's disease, a Harvey-Bradshaw index of > 5
15. Chronic kidney injury (eGFR < 59)
16. Pregnancy or lactation