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Active Drug (Sulfasalazine) for Primary Sclerosing Cholangitis (SHIP Trial)

Phase 2
Recruiting
Led By Joshua R Korzenik, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through the end of the study at week 22
Awards & highlights

SHIP Trial Summary

This trial will test whether sulfasalazine can help treat symptoms and reduce liver injury markers in patients with primary sclerosing cholangitis.

Who is the study for?
Adults and teens (15-80 years old) in the US with Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease can join. They must have had PSC for at least 6 months, elevated ALP levels, and be stable on or off a drug called ursodeoxycholic acid. Those with severe liver issues, recent drug/alcohol abuse, other liver diseases, sulfa allergies, major bowel surgery history or certain cancers can't participate.Check my eligibility
What is being tested?
The trial is testing if Sulfasalazine is better than a placebo at improving liver health and symptoms in PSC patients. Participants are randomly assigned to either get Sulfasalazine or a dummy pill without knowing which one they're taking. The study measures changes in liver injury markers like serum ALP.See study design
What are the potential side effects?
Sulfasalazine may cause side effects such as headaches, stomach upset, skin rashes or more serious reactions if you're allergic to sulfa drugs. It might also lead to changes in blood counts or kidney function which will be monitored during the trial.

SHIP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PSC for at least 6 months, confirmed by a special bile duct scan.
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I have been on a stable dose of UDCA for over 6 months or stopped it more than 4 weeks ago.
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I have been diagnosed with inflammatory bowel disease.
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I am between 15 and 80 years old.

SHIP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through the end of the study at week 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through the end of the study at week 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Normalization of ALP below the upper limit of normal
Reduction in Mean Alkaline Phosphatase (ALP)
Secondary outcome measures
Adverse Events
Changes in Mayo PSC risk score
Changes in Modified Fatigue Scale (MFS)
+3 more

SHIP Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Drug (Sulfasalazine)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,602 Previous Clinical Trials
11,463,183 Total Patients Enrolled
Joshua R Korzenik, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
42 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct locales is this experiment taking place?

"The list of medical centres that are currently enrolling participants in this study includes University of Pennsylvania, located in Philadelphia, Duke Univeristy's Durham branch and the Seattle based Duke University School of Medicine. Additionally there are 10 other sites across the world taking part."

Answered by AI

Am I eligible to enroll in this clinical trial?

"This trial is seeking 42 individuals with cholangitis between the ages of 15 and 80 years old. To qualify, they must meet specific prerequisites including: age within the stated range, a diagnosis of primary sclerosing cholangitis (PSC) for at least six months which has been determined via imaging techniques such as endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance cholangiopancreatography (MRCP), an alkaline phosphatase level above 1.67 times the upper limit of normal, inflammatory bowel disease, and either have maintained a stable dose of"

Answered by AI

Is eligibility for this trial limited to individuals less than 80 years old?

"The age range for this study encompasses individuals that are 15 years and older, but less than 80."

Answered by AI

Does this research endeavor require additional participants?

"Affirmative. According to clinicaltrials.gov, the recruitment for this research study is ongoing since it was introduced on July 1st 2018 and recently revised on March 4th 2022. 42 participants across 10 medical sites are needed in order to complete the trial."

Answered by AI

What is the aim of this research endeavor?

"As the main goal of this research, which is assessed between Baseline and Week 22, ALP levels need to be returned to within normal ranges. Secondary objectives include determining Unexpected and Serious Adverse Events, identifying any changes in Modified Fatigue Scale (MFS) scores, and evaluating Mayo PSC risk score alterations among patients."

Answered by AI

What additional experiments have been conducted with Sulfasalazine as the main agent?

"In 2007, University of Nebraska Medical Center first investigated the efficacy and safety of Sulfasalazine. 18354 trials have been finished and presently 9 are in progress, much of which is conducted around Philadelphia, Pennsylvania."

Answered by AI

What is the aggregate number of participants taken into account for this research program?

"This trial necessitates the recruitment of 42 qualified patients. Those interested can register at either the University of Pennsylvania in Philadelphia or Duke University in Durham."

Answered by AI

To what extent will Sulfasalazine offer long-term protection for patients?

"Our Power team has assessed the safety of Sulfasalazine to be a 2 as per Phase 2 trial standards, which suggests that there is some data demonstrating its security but no evidence for efficacy."

Answered by AI

What medical conditions is Active Drug (Sulfasalazine) typically prescribed to address?

"Polyarticular juvenile rheumatoid arthritis and unspecified chronic ailments can be effectively managed with Sulfasalazine. This pharmacological agent is also used to treat Crohn's disease, ulcerative colitis, and proctitis."

Answered by AI
~3 spots leftby Sep 2024