RECRUITING

Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

Conditions

Primary Sclerosing Cholangitis Sclerosing Cholangitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-07-01

Study Completion:2024-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03561584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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

Inclusion Criteria

Exclusion 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).

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

Contacts and Locations

Study Contact

Charu Madhwani Jain, MD, MPH

CONTACT

617-732-9119

cmjain@bwh.harvard.edu

Marin Waddington, BS, BS

CONTACT

6177329451

mwaddington@bwh.harvard.edu

Principal Investigator

Joshua R Korzenik, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Joshua R Korzenik, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-01

Study Completion Date2024-11-01

Study Record Updates

Study Start Date2018-07-01

Study Completion Date2024-11-01

Terms related to this study

Keywords Provided by Researchers

Sclerosing
Cholangitis

Additional Relevant MeSH Terms

Primary Sclerosing Cholangitis