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.

 

Ongoing Clinical Trials and Studies Conducted with PSC Partners Collaboration

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 survey, 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. Check www.clinicaltrials.gov to see the complete list of clinical trials in your area and to find out whether you may be eligible to join a clinical trial.

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; however, COVID-19 may be causing interruptions in recruitment. Contact the study for up-to-date information.

 

Sponsor or Research InstitutionStudy Title More Information(updated 6/3//21)

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

For adult PSC patients with Glossary Link pruritus. 26 US study locations, 13 US locations actively recruiting. Click here for more information.

Pliant Therapeutics

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

Phase 2a

For adult PSC patients. 23 Study locations in Australia, US, and Canada. Click here for more information.

Gilead Sciences

Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis (PRIMIS)

Phase 3

For adult PSC patients. 203 study locations. Click here for more information

Brigham & Women’s Hospital and Harvard University

Diet in PSC (DOCK Survey)

NA

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

Brigham & Women’s Hospital and Harvard University

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

NA

US residents 18 and over. Study conducted remotely. More info here.

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

Adults 18+, enrolling at MN, FL, and AZ Mayo sites. Contact study team to discuss eligibility. More info here.

 

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). 

SEARCH FOR PSC TRIALS 

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.

 INTERACTIVE MAP OF PSC TRIALS

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

Sample Map (as of May 2021)

Interactive Map

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.

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.

  • Mirum Pharmaceuticals
  • Pliant Therapeutics
  • HighTide Therapeutics
  • Gilead Sciences
  • CymbaBay 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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