What is a clinical trial?
Clinical trials are research studies conducted with people affected by HAE to evaluate whether a drug is safe and effective in humans. They are one of the final stages of the medical research and development process and follow strict standards to protect people. Clinical trials for investigational drugs typically go through three phases before Health Canada reviews and approves them.
Phase 1
Typically conducted with a small group, phase one trials help researchers understand the safety & tolerability of an investigational drug.
Phase 2
In phase two, researchers further test the safety and efficacy of a medicine as well as the correct dosages and effectiveness.
Phase 3
Typically conducted in a larger group, in phase three researchers assess the safety and potential effectiveness of a medicine.
Clinical trials are an essential part of drug development and are required to be conducted in Canada before a treatment can be approved by Health Canada and become available by prescription. If you are interested in participating in a trial, please contact a trial site to discover if you are eligible. If you do not live near a site, please contact either HAE Canada (office@haecanada.org) or the clinic directly for details about sponsored travel opportunities.
ALPHA-STAR Trial: STAR-0215
Astria Therapeutics
Berotralstat (ORLADEYO)
BioCryst Pharmaceuticals
CSL – 312 (Garadacimab)
CSL Behring
An Observational Study:
PROSPECT Study:
To review the Treatment and Outcomes of HAE patients with Normal C1-INH in Canada
Takeda
CSL – 312 (Garadacimab)
CSL Behring
KONFIDENT Study: Sebetralstat (KVD-900)
KalVista Pharmaceuticals
HAE CHAPTER-1 Study: PHV-S416
Pharvaris
Berotralstat (ORLADEYO)
BioCryst Pharmaceuticals
CSL-312 (Garadacimab)
CSL Behring
RAPIDe-1 Study: PHVS416
Pharvaris
EMPOWER Study: Lanadelumab (TAKHZYRO)
Takeda
Lanadelumab (TAKHZYRO)
Takeda
Updated: June 2023