General Information |
| Summary |
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia. |
| Description |
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia. |
| Clinical trials phase |
Phases 1/2 |
| Start date (estimated) |
2021-03-29 |
| End date (estimated) |
2028-01-31 |
| Clinical feature |
| Label |
type 1 diabetes mellitus |
| Link |
http://purl.obolibrary.org/obo/DOID_9744 |
| Description |
A diabetes mellitus that is characterized by destruction of pancreatic beta cells resulting in absent or extremely low insulin production.; Xref MGI.
OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT04786262 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04786262 |
| EudraCT number |
2022-002292-11 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04786262 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
medicalinfo@vrtx.com |
| Public email |
medicalinfo@vrtx.com |
| Last name |
Medical Information |
| Phone |
+1 617-341-6777 |
| Country |
|
|
| Sponsors |
Vertex Pharmaceuticals Incorporated
|
Cells |
| Which differentiated cell type is used |
| Label |
progenitor cell of endocrine pancreas |
| Link |
http://purl.obolibrary.org/obo/CL_0002351 |
| Description |
A progenitor cell that is able to differentiate into the pancreas alpha, beta and delta endocrine cells. This cell type expresses neurogenin-3 and Isl-1. |
|
Recruitment |
| Recruitment Status |
Recruiting |
| Estimated number of participants |
17 |
