Delaying Progression (Interventional Trials)

In the absence of a clear understanding of what causes Primary Sclerosing Cholangitis (PSC) and targeted therapies that address that cause(s), it is critically important to develop and test new therapies that delay the progression of PSC, buying patients more time with as much healthy, functional liver and bile duct tissue as possible.  Check out the trials below to learn what therapies are being tested to slow progression of PSC or to learn how to participate in one of these research studies.

Antifibrotics (Bile Ducts + Liver)

Immunomodulators

Antibiotics/Probiotics

Epigenetic Regulators

  • A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

Bile Acid Modifiers

Images L to R by Joy Worthington, Roger Chapman [CC BY 2.0 (http://creativecommons.org/licenses/by/2.0)], via Wikimedia Commons;  By Orrling and Tomer S (Own work); By Nephron (Own work) [CC BY-SA 3.0 (http://creativecommons.org/licenses/by-sa/3.0) or GFDL (http://www.gnu.org/copyleft/fdl.html)], via Wikimedia Commons

Itch_02

Symptom Management (Interventional Trials)

Anyone with PSC knows that beyond  the slow progression of the biliary disease that ultimately causes liver failure, the symptoms associated with liver and bile duct dysfunction are miserable.  Severe itching, known as pruritus, sleep disturbances, pain, and sometimes debilitating fatigue are leading symptoms associated with PSC.  Check out the trials below to learn what is being done to address these issues impacting quality of life in PSC or to learn how to participate in one of these research studies.

Natural History Studies and Observational Studies

In the absence of a clear understanding of what causes PSC, it is critically important to track PSC patients over time and study the underlying biology of this disease.  Check out the trials below to learn what studies are ongoing that may shed more light on the nature of PSC.

PSC/AIH Overlap Studies

  • MRI Based Biomarkers in Pediatric Autoimmune Liver Disease
  • MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease
  • Opening Soon:  A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiH (Merlin)

Diagnostic Development

Read here about trials focused on developing new ways to diagnose PSC and similar, related, or overlapping conditions, including cancers common in PSC.

  • Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis  
  • Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease (OCEANIA) 

  • Opening Soon: Comparison of Diagnostic Accuracy Before and After Stricture Dilation in Biliary Stricture 

  • Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy for PSC Biliary Strictures (PSCRegistry)
Cholangiocarcinoma

Cancer (Interventional Trials)

People with PSC are at increased risk of developing multiple types of cancer.  If you have been diagnosed with cancer in the setting of PSC, check out the trials below, which may be relevant to your situation, and discuss with your physician(s) as early as possible whether you should enroll in a clinical trial.  Some of these trials may not apply to your situation depending on the state of your autoimmune disease or if your liver function does not meet criteria for enrollment.  These listings are meant to inform discussions with your doctor.  If you are aware of a clinical trial for cancer that may be of relevance to patients with PSC that is not listed here, please contact us so we can include that information in this list.  Please contact us if you have a cancer diagnosis in PSC and need help being connected with additional resources, or call us at +1 (412) 447-0900.

Cholangiocarcinoma (CCA)

More CCA trials at clinicaltrials.gov

Colorectal Cancer (CRC)

Hepatocellular Carcinoma (HCC)

  • Coming Soon.