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View trial details
Overview
Official protocol title:
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.
Intervention/treatment:
Name given to the drug used in the clinical trial. This may be a code name, a chemical name of the active ingredient, a non-proprietary name or brand name.
ASTEGOLIMAB
Medical condition:
The disease or condition that's being studied in the clinical trial.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Protocol code:
An alpha-numeric sequence generated by the sponsor that can vary in length. Used as a reference to help identify a specific clinical trial protocol. Formerly referred to as 'protocol number'.
GB44332
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
269892
Status:
The status for the clinical trial as a whole. Note that the status for each site may be different and should always be confirmed with the clinical trial sponsor. Health Canada uses information provided by the sponsor to an international clinical trial registry to determine status values for each clinical trial. Status values on the portal can include:
• Not yet recruiting - Participants are not yet being recruited or enrolled at any site.
• Recruiting - Participants are currently being recruited.
• Active, not recruiting - The clinical trial is ongoing but new participants are not currently being recruited or enrolled.
• On hold - The clinical trial has been temporarily stopped, but it may start again.
• Closed - The clinical trial has either ended normally and participants are no longer being examined or treated, or it has stopped early and will not start again.
• Unknown - The status of the clinical trial has not been verified in the registry in the last 2 years. Please contact the sponsor.
• No match, ongoing - Please contact sponsor for status information.
• Other - Please contact sponsor for status information.
Active, not recruiting
Approved:
The date that the clinical trial has been determined to meet Health Canada’s regulatory requirements. For drug clinical trials, this means that a no objection letter or an authorization was issued.
December 21, 2022
Trial phase:
The stage of a clinical trial, based on factors such as the objectives of the trial and number of participants. Phase data displayed in the portal is taken from international registry data.
For more information see "Phases of drug trials" on the Definitions webpage
Phase 3
For more information:
ClinicalTrials.gov -
NCT05595642
This is an external link. The information is not authorized by the Government of Canada.
Eligibility
The characteristics people must have or the requirements they must meet to participate in the clinical trial. Eligibility criteria include both inclusion criteria (must have for a person to participate) and exclusion criteria (prevent a person from participating).
Review the exact criteria from the registry or the sponsor before making a decision to participate. The following values may be available on the portal:
Sex: an eligibility criteria based on biological characteristics. Information in the portal is based on available data and will default to 'all' when no other data is available.
Age: The age a person must be to participate in the clinical trial.
Accepts Healthy Volunteers: People who do not have the disease or condition can participate in the clinical trial.
Sex:
ALL
Accepts healthy volunteers:
No
Locations
Alberta
Edmonton Respiratory Consultants
Edmonton, Alberta, T5J 3S9
COMPLETED
Synergy Respiratory & Cardiac Care - Synergy Wellness Centre Location
Sherwood Park, Alberta, T8H 0N2
WITHDRAWN
British Columbia
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
COMPLETED
Ontario
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 1T3
COMPLETED
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X 5A6
COMPLETED
Dynamic Drug Advancement Ltd.
Ajax, Ontario, L1S 2J5
COMPLETED
Inspiration Research
Toronto, Ontario, M5T 3A9
COMPLETED
Quebec
Centre Hospitalier de l'Universite Laval
Québec, Quebec, G1V 4G5
COMPLETED
Clinique de pneumologie et du sommeil de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 2B4
COMPLETED
Recherche GCP Research
Montreal, Quebec, H1Y 3H5
COMPLETED
