Clinical Trials in Canada

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 to see if there are opportunities for sponsored travel through the pharmaceutical companies.

Recruiting

Treatment Name

Name of Clinical Trial

Trial Location

Further Details

CSL312 (Garadacimab)

Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

Edmonton, AB
Hamilton, ON
Montreal, QC
Ottawa, ON
Quebec City, QC
Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for further details on the CSL Behring website

KVD 824

oral treatment

KOMPLETE Study: Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II.

Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for details on the KalVista website

KVD 900 (Sebetralstat)

oral treatment

KONFIDENT Study: A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD-900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with HAE

Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for details on the KalVista website

Lanadelumab

Expanded Access for the Prevention of Acute Attacks of HAE in Pediatric Participants Aged 2 to Less Than (<) 12 Years

Ottawa, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information on Takeda’s website

PHA-022121

oral treatment

RAPIDe-1 Study: Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With HAE Type I or Type II 

Edmonton, AB
Montreal, QC
Ottawa,ON
Quebec City, QC
Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information on Pharvaris’s website

PHA-022121

oral treatment

HAE CHAPTER-1 Study: Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With HAE Type I or Type II.

Ottawa, ON

Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information on Pharvaris’s website

Active, Not Recruiting

Treatment Name

Name of Clinical Trial

Trial Location

Further Details

BCX 7353 (Berotralstat)

Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2) / Phase 3

Ottawa, ON

Quebec City, QC

Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information the BioCryst website

CSL312 (Garadacimab)

CSL312 (Garadacimab) in the Prevention of HAE Attacks / Phase 3

Edmonton, AB

Ottawa, ON

Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information the CSL Behring website

Lanadelumab

A Study of Lanadelumab in Persons With HAE Type I or II in North America (EMPOWER)

Calgary, AB
Hamilton, ON
Montreal, QC
Quebec City, QC
Toronto, ON

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information on Takeda’s website

Lanadelumab

A Study of Lanadelumab in Teenagers and Adults to Prevent Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

Ottawa, ON

Quebec City, QC

CLICK HERE for trial information on ClinicalTrials.gov
CLICK HERE for trial information on Takeda’s website