Clinical trials

Participating in a clinical trial or taking part in a research study can be a very rewarding way to get involved in helping to ensure all patients have access to safe and effective treatments. Trials are run on a stepped basis, overseen by regulators like the FDA. Each phase expands the numbers of participants and if successful brings the proposed treatment to approval. Phase I trial – safety. Phase II trial – safety and dose. Phase III trial – safety and efficacy. Phase IV trials – post approval surveillance.

Now recruiting PBC patients in Canada

There are many clinical trials taking place in Canada (list updated August 2022).  If you are interested in participating in any of these trials, ask your specialist to find out if you would benefit from and/or qualify for any of these clinical trials.

  • SELADELPAR (Gilead) – Open Label, long term:  Toronto and Calgary. Learn more about what’s involved and how to enroll.  Also, read more about the study and worldwide locations on clinicaltrials.gov.
  • ELAFIBRANOR (Ipsen) – Phase 3 trial active fully enrolled: Vancouver, Calgary, Winnipeg & Montreal. Read more about the study and worldwide locations on  clinicaltrials.gov. 
  • LINERIXIBAT (GSK) – FOR PBC ITCHPhase 3 long term study fully enrolled. Read more about the study and worldwide locations on clinicaltrials.gov.  Open Label, long term now enrolling: Toronto and Montreal. Read more about this study and worldwide locations on: clinicaltrials.gov.
  • VOLIXIBAT (Mirum) –  FOR PBC ITCH -Phase 2 trial now enrolling – Learn more on clinical trials.gov – now enrolling in Vancouver & Calgary
  • PEMAFIBRATE (Kowa) – Phase 2 study now enrolling: Vancouver, North Bay, Toronto, and Montreal. Learn more about the study and worldwide locations on clinical trials.gov

Other active/upcoming PBC clinical trials

  • OCA + BZF (Intercept) – Phase 2 study now enrolling.  Learn more about the study and worldwide locations on clinicaltrials.gov no active sites in Canada
  • CNP-104 (COUR) – Phase 2a now enrolling.  Learn more about the study and locations on clinicaltrials.gov – no active sites in Canada
  • SELADELPAR (GILEAD) – Phase 3 trial AFFIRM now enrolling . Learn more about the study and worldwide locations on clinicaltrials.gov  -no active sites in Canada
  • SELADELPAR (GILEAD) – Phase 3 trial (IDEAL) now enrolling: Learn more about the study and worldwide locations on clinical trials.gov – no active sites in Canada

Terminated or completed PBC clinical trials

  • SETANAXIB (Calliditas) – Phase 2b TRANSFORM trial – study completed. Read more about the study on clinicaltrials.gov. 
  • EP547 (Escient) –  FOR PBC ITCH Phase 2 PACIFIC study completed. Read more about the study on clinicaltrials.gov 
  • OCALIVA (Advanz)  – Phase 4 COBALT long term study terminated.
  • SAROGLITAZER MAGNESIUM (Zydus) – Phase 2b/3 trial  completed.
  • EDP-305 (Enanta) – terminated
  • ABATACEPT (Bristol-Myers Squibb) – terminated
  • CILOFEXOR (Gilead) – terminated
  • ETRASIMOD (Arena) – terminated
  • TROPIFEXOR (Novartis) – terminated

To see ALL PBC CLINICAL TRIALS, check:

www.clinicaltrials.gov
or use the CLINICAL TRIAL search tool below: