A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Sponsor
ICM Co. Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05752032
Collaborator
(none)
16
2
69.1
8
0.1
Study Details
Study Description
Brief Summary
This is an observational study of the long term safety and efficacy of ICM-203.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
16 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Anticipated Study Start Date
:
Mar 1, 2023
Anticipated Primary Completion Date
:
Dec 1, 2028
Anticipated Study Completion Date
:
Dec 1, 2028
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ICM-203 Participants who previously received ICM-203 in ICM-203 clinical studies |
Genetic: ICM-203
Long term follow-up
|
| Placebo Participants who previously received placebo in ICM-203 clinical studies |
Drug: Placebo
Long term follow-up
|
Outcome Measures
Primary Outcome Measures
- Incidence of delayed adverse events [Up to 5 years]
Secondary Outcome Measures
- Incidence of total knee replacement [Up to 5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Previous receipt of ICM-203 or matching placebo
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 2 | Barwon Health | Geelong | Victoria | Australia | 3220 |
Sponsors and Collaborators
- ICM Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ICM Co. Ltd.
ClinicalTrials.gov Identifier:
NCT05752032
Other Study ID Numbers:
- ICM 20-1002
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 2, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ICM Co. Ltd.
Additional relevant MeSH terms: