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Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (SHIP)

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ClinicalTrials.gov Identifier: NCT03561584
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : October 18, 2018
Sponsor:
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

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 : January 1, 2020
Estimated Study Completion Date : April 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



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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
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).

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 ClinicalTrials.gov identifier (NCT number): NCT03561584


Contacts
Contact: Fernanda Quevedo 617-732-9173 squevedo@bwh.harvard.edu
Contact: Joshua Korzenik, MD 617-732-9173 jkorzenik@bwh.harvard.edu

Locations
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, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Fernanda Quevedo    617-732-9676    squevedo@bwh.harvard.edu   
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, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Stacey Smith         
Principal Investigator: Andrew Muir         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen Mccauley         
Principal Investigator: David Goldberg, MD         
Sponsors and Collaborators
Brigham and Women's Hospital

Responsible Party: Joshua Korzenik, Director, Crohn's and Colitis Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03561584     History of Changes
Other Study ID Numbers: 2018P000019
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Sclerosing
Cholangitis

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Sulfasalazine
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents