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Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TTHX1114 weekly x 5 | Experimental | TTHX1114 via IC injection weekly x 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTHX1114 | Drug | engineered FGF-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specular Microscopy | Corneal Endothelial Cell Density | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pachymetry | Central Corneal Thickness | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
Prior exposure to TTHX1114
Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
History of:
Use of any concomitant medications that may interfere with the assessment of safety and efficacy
Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Tremblay | Trefoil Therapeutics.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trefoil Study Site | Atlanta | Georgia | 30342 | United States | ||
| Trefoil Study Site |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 2024 | Oct 23, 2024 | 8 |
| ID | Term |
|---|---|
| C562745 | Corneal Dystrophy, Posterior Polymorphous, 1 |
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| Washington |
| Missouri |
| 30090 |
| United States |