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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 : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Joshua Korzenik, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE May 14, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • 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
  • 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
  • Adverse Events [ Time Frame: Baseline through the end of the Study at Week 22 ]
    Unexpected and Serious Adverse Events will be examined
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis
Official Title  ICMJE A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE
  • Drug: Sulfasalazine
    Patients will be initiated on a low dose of sulfasalazine (500 mg) twice daily (bid). Dosage will be increased throughout the study.
  • Drug: Placebo
    Patients will be initiated on 1 placebo tablet twice daily (bid). Dosage will be increased throughout the study.
Study Arms  ICMJE
  • Active Comparator: Active Drug (Sulfasalazine)
    Intervention: Drug: Sulfasalazine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fernanda Quevedo 617-732-9173 squevedo@bwh.harvard.edu
Contact: Joshua Korzenik, MD 617-732-9173 jkorzenik@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03561584
Other Study ID Numbers  ICMJE 2018P000019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joshua Korzenik, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP