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View trial details
Overview
Official protocol title:
FIRST-IN-HUMAN STUDY OF AK1320 ENCAPSULATED MICROSPHERES (AK1320 MS) IN SUBJECTS WITH DEGENERATIVE SPONDYLOLISTHESIS AND CONCOMITANT SYMPTOMATIC SPINAL STENOSIS WHO ARE UNDERGOING DECOMPRESSION AND SINGLE LEVEL INSTRUMENTED POSTEROLATERAL LUMBAR AUTOGRAFT FUSION SURGERY
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.
AK1320
Medical condition:
The disease or condition that's being studied in the clinical trial.
DEGENERATIVE SPONDYLOLISTHESIS
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'.
AK1320-101
Control number:
A unique 6-digit identification number Health Canada assigns to each clinical trial application.
239244
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.
Closed
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.
June 04, 2020
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 1
For more information:
ClinicalTrials.gov -
NCT04483297
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
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Ontario
London Health Sciences Centre
Sunnybrook Health Sciences Centre
Quebec
Centre Hospitalier Universitaire de Québec Laval
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, H4J 1C5
Montreal General Hospital
Montreal, Quebec, H3G 1A4
