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Clinical Trials

Clinical trials and research studies offer an opportunity for patients to participate in scientific and drug development research. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants’ behavior, such as diet. Researchers will need your input through various surveys the Registry team will ask you to complete. You are the PSC patient's voice.

One important function of the Registry is to assist in connecting PSC patients with clinical trials or studies for which they may be eligible. Based upon a Registry participant’s answers to the patient surveys, a participant may receive an email with information about a clinical trial that is recruiting PSC patients. You can also visit this page anytime to see the list of clinical trials conducted by drug developers working with the PSC Partners Patient Registry team. 

 

PSC Partners is collaborating with pharmaceutical companies planning and conducting clinical trials by adding your patient perspective to the trial protocol; by representing the patient voice throughout the drug development process; and by sharing clinical-trial information with the PSC community. Check this site often, as new clinical trials will be added as soon as they launch. The following clinical trials and studies are recruiting PSC patients. Contact the study for up-to-date information.

An overview of the phases of clinical trials can be found here (source FDA).

PSC Clinical Trials

♦ Indicates Studies Conducted with PSC Partners Collaboration or Input

Sponsor or Research Institution

Study Title & Phase

Details (updated 7/2024)

Links

Arbor Research, NIH (NIDDK) and ChiLDReN, the Childhood Liver Disease Research Network

Primary Sclerosing Cholangitis in Children: a 10-year Prospective Natural History Study in PSC

Recruiting: Seeking 700 pediatric (ages 2-25) patients at multiple sites in North America for observational study. Study sites can be found at clinicaltrials.gov listing.


ClinicalTrials.gov Identifier: NCT04181138

Brigham & Women's Hospital and Harvard University

Detoxification of the Liver In PSC (DoLPHin)

Phase 2 Study

Recruiting: For adult PSC patients who live in the US. All study visits will take place remotely, and a nurse will visit your home to draw labs.


ClinicalTrials.gov Identifier: NCT05835505

Brigham & Women’s Hospital and Harvard University

Diet in PSC (DOCK Survey)

Pilot Study

Open Survey: US residents 18 and over: If you haven't already, please complete this short PSC nutrition survey.

Brigham & Women’s Hospital and Harvard University

Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (SHIP)

Phase 2 Study

Recruiting: For PSC patients aged 15 - 80. 12 Study locations in the US and patients can be enrolled anywhere in the US with nurse coming to your home to draw labs, provide medication, etc.


ClinicalTrials.gov Identifier: NCT03561584

 

Brigham & Women’s Hospital and Harvard University

The Role of Diet and Nutrition in PSC (DINER Study)

Active, not recruiting:


ClinicalTrials.gov Identifier: NCT04678219

 

Chemomab

CM-101 in PSC Patients - The SPRING Study

Phase 2a Study

Active, not recruiting: Germany, Israel, Spain, UK, US.


ClinicalTrials.gov Identifier: NCT04595825

Escient Pharmaceuticals

Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis (PACIFIC)

Phase 2 Study

Active, Not Recruiting: Adults 18-80 for interventional study at multiple sites in US and Canada. If you are not located within close proximity to any of the listed study locations, or if you are unable to, or do not wish to travel to a study site, it may be possible for you to participate in the study from home.


ClinicalTrials.gov Identifier: NCT05525520

European Joint Program on Rare Diseases and national funding agencies in Germany, Canada, Belgium, Poland and Hungary

Improving health-related quality of life in patients with rare autoimmune liver diseases by structured peer-delivered support: a transnational effectiveness-implementation hybrid trial

Active, Not Recruiting: Belgium (Ghent), Canada (Toronto), Germany (Hamburg-Eppendorf), Hungary (Debrecen), and Poland (Warsaw)


Trial Registration: ISRCTN15030282

Ipsen Pharmaceuticals

A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. (ELMWOOD)

Phase 2 Study

Recruiting: For adult PSC patients. US, Canada and Spain study locations.


ClinicalTrials.gov Identifier: NCT05627362

Mayo Clinic

Vancomycin for Primary Sclerosing Cholangitis - The purpose is to assess the effects of different oral vancomycin doses on the clinical and biochemical course in adult patients with PSC.

Phase 2 Study

Active, Temporary Pause in Recruiting (check back soon): Adults 18-75, enrolling at MN, FL, and AZ Mayo sites. Contact study team to discuss eligibility.


ClinicalTrials.gov Identifier: NCT03710122

Mirum Pharmaceuticals

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (VISTAS)

Phase 2 Study

New Inclusion Criteria. Recruiting: For PSC patients including AIH-PSC, both large and small-duct PSC, ages 12+, with any level of pruritus. 26+ US and Canada study sites and virtual participation option.


ClinicalTrials.gov Identifier: NCT04663308

National Institutes of Health: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach

Recruiting: Observational study for adult PSC patients and controls living in same household.


ClinicalTrials.gov Identifier: NCT04685200

University of Minnesota

Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC

Early Phase 1 Study

Recruiting: Seeking 28 adults aged 18-76. Visits take place at University of Minnesota Medical Center.


ClinicalTrials.gov Identifier: NCT06197308

ClinicalTrials.gov Website

ClinicalTrials.gov is a website that records clinical trials being conducted around the world. This website is maintained by the National Library of Medicine (NLM) at the US National Institutes of Health (NIH). 

Above link will list all interventional trials on ClinicalTrials.gov for PSC that are recruiting, not-yet recruiting, active but not recruiting, and enrolling by invitation.

Above link will open an interactive map showing where the above listed trials are taking place.

Sample Map (as of December 2023)

World map with labeled active clinical trials in each region. 13 in USA, 5 in Canada, 11 in Europe, 3 in Middle East, 1 in China, 1 in Australia & Oceania

Information about planned, ongoing, paused, and completed trials for PSC and a wide range of other diseases and conditions can also be found on this site. Visit ClinicalTrials.gov to explore the status of all clinical trials in PSC. More information about the ClinicalTrials.gov site can be found here.

European Union Residents: Visit the EU Clinical Trials Register here to see active clinical trials in the EU.

United Kingdom Residents: Visit the PSC Support UK Clinical Trials page for an interactive list and map of active clinical trials in the UK.

History of Collaboration

The following is a list of trial sponsors with whom PSC Partners Patient Registry has worked or is working to provide the patient voice and recruitment support. Visit Registry Impact to see a listing of publications and studies that have resulted from collaboration with the PSC Partners Patient Registry.

  • Ipsen Pharmaceuticals

  • Chemomab Therapeutics

  • Mirum Pharmaceuticals

  • Pliant Therapeutics

  • Escient Pharmaceuticals

  • HighTide Therapeutics

  • Gilead Sciences

  • CymaBay Therapeutics

  • NGM Biopharmaceuticals

  • Takeda Pharmaceuticals

  • Intercept Pharmaceuticals

  • Lumena Pharmaceuticals

  • Shire Pharmaceuticals

  • Durect Pharmaceuticals

  • Tobira Therapeutics

  • Conatus Pharmaceuticals

  • GlaxoSmithKline (GSK)

  • Patara Pharma

  • Albireo Pharma
     

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