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Active Drug (Sulfasalazine) for Primary Sclerosing Cholangitis (SHIP Trial)
SHIP Trial Summary
This trial will test whether sulfasalazine can help treat symptoms and reduce liver injury markers in patients with primary sclerosing cholangitis.
SHIP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSHIP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SHIP Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
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."
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."
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."
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