“A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” (WHO)
Clinical trials offer an opportunity for patients to participate in scientific and industry 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.
The following clinical trials are recruiting PSC patients. PSC Partners is collaborating with the pharmaceutical companies conducting these clinical trials by adding our patient perspective to the trial protocol and by sharing clinical-trial information with the PSC community.
Currently Recruiting in Canada
As of Feb 2020, there are two clinical trials currently recruiting PSC patients in Canada. There may be other research projects in which you may be involved. Before participating in a study, discuss the risks and potential benefits with your health care provider.
- High Tide HTD1801: “HTD1801, berberine ursodeoxycholate, is an oral investigational drug developed by HighTide to treat Primary Sclerosing Cholangitis. The Food and Drug Administration (FDA) granted HighTide “Fast Track” designation for HTD1801 in the treatment of PSC, in recognition that HTD1801 has the potential to address an unmet medical need based on data shared with the FDA. To our knowledge, HTD1801 is the only drug to receive fast track designation for PSC.” Visit psclinicaltrials.com for more information or at the NIH clinical trial database listing of this trial. This trial is scheduled to complete enrolment March 31, 2020.
- Gilead PRIMIS: Have you checked out this Phase 3 trial for PSC? PSC Partners is collaborating with Gilead Sciences, Inc, the sponsor, in providing the patient voice as well as community engagement and outreach for the PRIMIS Phase 3 PSC study, which is currently recruiting non-cirrhotic adult patients with PSC. For more information, please click on https://www.psctrial.com/. The NIH clinical trial database listing of this trial can be found here.
Additional Information on Clinical Trials
- Please see the article in Volume 1, Issue 2 of the Loon Duct about Clinical Trials in Canada. This can be found here.
- Visit the US-based PSC Partners website content on clinical trials.
- clinicaltrials.gov a searchable database of privately and publicly funded clinical studies conducted around the world.