Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03561584
• Date of registration: 14/05/2018
• Prospective Registration: Yes
• Primary sponsor: Brigham and Women's Hospital
• Public title: Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis SHIP
• Scientific title: A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)
• Date of first enrolment: July 1, 2018
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03561584
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Joshua R Korzenik, MD
• Affiliation: Brigham and Women's Hospital

• Name: Charu Madhwani Jain, MD, MPH

• Name: Charu Madhwani Jain, MD, MPH

Key inclusion & exclusion criteria

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



Age minimum: 15 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: Placebo

Drug: Sulfasalazine

Primary Outcome(s)

Normalization of ALP below the upper limit of normal [Time Frame: Baseline through the end of the Study at Week 22]

Reduction in Mean Alkaline Phosphatase (ALP) [Time Frame: Baseline through the end of the Study at Week 22]

Secondary Outcome(s)

Overall changes in ALP levels [Time Frame: Baseline through the end of the Study at Week 22]

Changes in pruritus visual analog scale (VAS) [Time Frame: Baseline through the end of the Study at Week 22]

Changes in blood tests [Time Frame: Baseline through the end of the Study at Week 22]

Changes in Mayo PSC risk score [Time Frame: Baseline through the end of the Study at Week 22]

Adverse Events [Time Frame: Baseline through the end of the Study at Week 22]

Changes in Modified Fatigue Scale (MFS) [Time Frame: Baseline through the end of the Study at Week 22]

Secondary ID(s)

2018P000019

Source(s) of Monetary Support

Please refer to primary and secondary sponsors