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Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (SHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03561584
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : January 28, 2020
Information provided by (Responsible Party):
Joshua Korzenik, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Sulfasalazine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: There are two arms in this trial: active drug and placebo.
Masking: Double (Participant, Care Provider)
Masking Description: Participants and Providers will be masked until Week 14. If a subject continues past week 14, the study becomes Open-Label and participants are given the option to continue on the active drug for an additional 8 weeks.
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Active Comparator: Active Drug (Sulfasalazine) Drug: Sulfasalazine
Patients will be initiated on a low dose of sulfasalazine (500 mg) twice daily (bid). Dosage will be increased throughout the study.

Placebo Comparator: Placebo Drug: Placebo
Patients will be initiated on 1 placebo tablet twice daily (bid). Dosage will be increased throughout the study.

Primary Outcome Measures :
  1. Reduction in Mean Alkaline Phosphatase (ALP) [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Proportion of patients with reduction of mean ALP < 1.5 x ULN at end of treatment

  2. Normalization of ALP below the upper limit of normal [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Assessment in number of patients whose ALP normalizes

Secondary Outcome Measures :
  1. Overall changes in ALP levels [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Proportion of patients with ALP > or < 1.5 x ULN at end of treatment

  2. Changes in blood tests [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Change in mean Liver Function Tests (e.g. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), total bilirubin) and C-reactive Protein

  3. Adverse Events [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Unexpected and Serious Adverse Events will be examined

  4. Changes in Mayo PSC risk score [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Number of patients with changes in Mayo PSC risk score

  5. Changes in Modified Fatigue Scale (MFS) [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Number of patients with changes in MFS score

  6. Changes in pruritus visual analog scale (VAS) [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Number of patients with changes in VAS score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03561584

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Contact: Fernanda Quevedo 617-732-9173
Contact: Joshua Korzenik, MD 617-732-9173

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United States, California
University of California, Davis Recruiting
Davis, California, United States, 95616
Contact: Sandeep Dhaliwal         
Principal Investigator: Chris Bowlus, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Andrea Elibero         
Principal Investigator: Cynthia Levy, MD         
Sub-Investigator: Diane Sabogal, NP         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Arley Donovan         
Principal Investigator: Dan Pratt, M.D.         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Fernanda Quevedo    617-732-9173   
Principal Investigator: Joshua Korzenik, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Donna Rush         
Principal Investigator: Stuart Gordon, MD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63105
Contact: Michael Klebert         
Principal Investigator: Scott McHenry         
Sub-Investigator: Mauricio Lisker-Melman         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Christy Walters         
Principal Investigator: Andrew Muir         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen Mccauley         
Principal Investigator: David Goldberg, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: LyTieng Huot         
Principal Investigator: Kiran Bambha         
Sponsors and Collaborators
Brigham and Women's Hospital
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Responsible Party: Joshua Korzenik, Director, Crohn's and Colitis Center, Brigham and Women's Hospital Identifier: NCT03561584    
Other Study ID Numbers: 2018P000019
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joshua Korzenik, Brigham and Women's Hospital:
Additional relevant MeSH terms:
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Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents