Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515583-32-00 | Other Identifier | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-264 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-264 | Drug | Allogeneic human stem cell-derived islets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to 24 months | |
| Part B: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT) | From Baseline and at Day 90 |
Not provided
Not provided
Key Inclusion Criteria:
Clinical history of T1D with greater than or equal to (>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study
Key Exclusion Criteria:
Prior islet cell transplant, organ transplant, or cell therapy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHealth Diabetes Research Institute | Miami | Florida | 33136 | United States | ||
| University of Chicago |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chicago |
| Illinois |
| 60637 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center Montefiore | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| University of Alberta, Edmonton | Edmonton | Canada |
| Montreal Clinical Research Institute | Montreal | Canada |
| Toronto General Hospital (TGH) | Toronto | Canada |
| Vancouver General Hospital | Vancouver | Canada |
| Dresden Center for Islet Transplantation | Dresden | Germany |
| IRCCS Ospedale San Raffaele | Milan | Italy |
| Leiden University | Leiden | Netherlands |
| Hopiteaux Universitaires de Geneve | Geneva | Switzerland |
| Churchill Hospital | Headington | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | United Kingdom |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided