At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 52 target
Drug / intervention
VX-880biological
Likely dose
Not stated in record
Key inclusion· 4
- ✓Type 1 diabetes with over 5 years of insulin dependence
- ✓At least two documented severe hypoglycemia episodes in the 12 months prior to enrollment
- ✓Stable diabetic treatment
- ✓Consistent continuous glucose monitor (CGM) use for at least 3 months before screening and willingness to continue
Key exclusion· 3
- ✕Prior islet cell transplant
- ✕Prior organ transplant
- ✕Prior cell therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2/3 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
In Brief
A Phase 3 clinical trial evaluating VX-880 for Diabetes Mellitus, Type 1 and 2 related conditions. Currently recruiting, targeting 52 participants across 29 sites in 10 countries.
Detailed Summary
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France, Germany, Italy, Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3Recruiting
2021202220232024202520262027202820292030
First PostedMar 2021
Enrollment StartMar 2021
TodayJul 2026
Primary CompletionJun 2027
Study CompletionJun 2030
First PostedMar 8, 2021
Enrollment StartMar 29, 2021
Primary CompletionJun 30, 2027
Study CompletionJun 30, 2030
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 5.3 years agoPrimary completion in 12 months
Arms & Interventions
VX-880experimental
Biological: VX-880
Interventions
VX-880biological
Infused into the hepatic portal vein.