Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:15 - 80
Updated:1/13/2019
Start Date:July 1, 2018
End Date:April 1, 2020
Contact:Fernanda Quevedo
Email:squevedo@bwh.harvard.edu
Phone:617-732-9173

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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.


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. Treatment with antibiotics within 3 months of start of medication

13. Need for chronic use of antibiotics

14. Evidence of bacterial cholangitis within 6 months of enrollment

15. In patients with Ulcerative Colitis, simple clinical colitis activity index of > 4 or,
if Crohn's disease, a Harvey-Bradshaw index of > 5

16. Chronic kidney injury (eGFR < 59)

17. Pregnancy or lactation
We found this trial at
8
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Dan Pratt, M.D.
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Joshua Korzenik, MD
Phone: 617-732-9676
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Andrew Muir
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Cynthia Levy, MD
University of Miami A private research university with more than 15,000 students from around the...
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3505 Gaston Avenue
Dallas, Texas 75246
Principal Investigator: Robert Rahimi, M.D.
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Davis, California 95616
Principal Investigator: Chris Bowlus, MD
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Detroit, Michigan 48202
Principal Investigator: Stuart Gordon, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: David Goldberg, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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