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Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis — SHIP  

Primary Sclerosing Cholangitis Clinical Trial

Official title:
A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)

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. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled.

Clinical Trial Description

As there is a strong association between PSC and IBD, it is reasonable to hypothesize that a therapy of proven benefit for UC may prove to also be effective for PSC. Unfortunately, several therapies which are indicated for the treatment of UC have not been effective in PSC including anti-TNF therapies and other anti-inflammatory medications. Sulfasalazine and mesalamine, medications commonly used for the treatment of UC, may be exceptions to this trend. While this therapy has never been formally tested in PSC, some retrospective reports suggest a possible benefit. Our current understanding of the mechanism of action of these medications suggests there is reasonable to believe they may also be effective in PSC. We are recruiting remotely throughout the United States so an individual anywhere in the US with PSC and IBD can be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03561584
Study type Interventional
Source Brigham and Women's Hospital
Contact Charu Madhwani Jain, MD, MPH
Phone 617-732-9119
Email cmjain@bwh.harvard.edu
Status Recruiting
Phase Phase 2
Start date July 1, 2018
Completion date November 1, 2024
View Details
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