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Clinical Trial Details

Trial ID: L3732
Source ID: NCT05791201
Associated Drug: Vx-264
Title: A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: VX-264
Outcome Measures: Primary: 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 and Part C: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT), From Baseline and at Day 90 | Secondary: Part C: Change in peak C-peptide during MMTT, From Baseline up to 24 months|Part C: Change in Average Total Daily Insulin Dose, From Baseline up to 24 months|Part C: Proportion of Participants who are Insulin Independent at One Point in Time, From Day 180 up to Day 365|Part C: Change in HbA1c values, From Baseline up to 24 months
Sponsor/Collaborators: Sponsor: Vertex Pharmaceuticals Incorporated
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 17
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-16
Completion Date: 2026-05
Results First Posted:
Last Update Posted: 2024-12-06
Locations: UHealth Diabetes Research Institute, Miami, Florida, 33136, United States|University of Chicago, 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, Geneve, Switzerland|Churchill Hospital, Headington, United Kingdom|Royal Victoria Infirmary, Newcastle Upon Tyne, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05791201