Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (NCT03561584) | Clinical Trial Compass
CompletedPhase 2
Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis
United States32 participantsStarted 2018-07-01
Plain-language 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.
We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.
Who can participate
Age range15 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 15-80
✓. 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.
✓. ALP \> 1.67 times the upper limit of normal (ULN) at screening
✓. Inflammatory bowel disease
✓. 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
✕. Anticipated need for liver transplant within one year as determined by Mayo PSC risk score treatment
✕. Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
✕. Evidence of advanced liver disease including MELD score \> 10, bilirubin \> 3.0, platelet count \< 100,000; or INR \> 1.4
✕. 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
✕. Secondary causes of sclerosing cholangitis
✕. Known intolerance to sulfasalazine (including but not limited to allergy to sulfa or mesalamine) or folic acid
What they're measuring
1
Reduction in Mean Alkaline Phosphatase (ALP)
Timeframe: Baseline through the end of the Study at Week 22
2
Normalization of ALP below the upper limit of normal
Timeframe: Baseline through the end of the Study at Week 22