Primary Sclerosing Cholangitis Clinical Trial
— SHIPOfficial title:
A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)
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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | November 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 80 Years |
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). We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Chestnut Hill | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Mean Alkaline Phosphatase (ALP) | Proportion of patients with reduction of mean ALP < 1.5 x ULN at end of treatment | Baseline through the end of the Study at Week 22 | |
Primary | Normalization of ALP below the upper limit of normal | Assessment in number of patients whose ALP normalizes | Baseline through the end of the Study at Week 22 | |
Secondary | Overall changes in ALP levels | Proportion of patients with ALP > or < 1.5 x ULN at end of treatment | Baseline through the end of the Study at Week 22 | |
Secondary | Changes in blood tests | Change in mean Liver Function Tests (e.g. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin) and C-reactive Protein | Baseline through the end of the Study at Week 22 | |
Secondary | Adverse Events | Unexpected and Serious Adverse Events will be examined | Baseline through the end of the Study at Week 22 | |
Secondary | Changes in Mayo PSC risk score | Number of patients with changes in Mayo PSC risk score | Baseline through the end of the Study at Week 22 | |
Secondary | Changes in Modified Fatigue Scale (MFS) | Number of patients with changes in MFS score | Baseline through the end of the Study at Week 22 | |
Secondary | Changes in pruritus visual analog scale (VAS) | Number of patients with changes in VAS score | Baseline through the end of the Study at Week 22 |
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