A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
NCT ID: NCT04786262
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
52 participants
INTERVENTIONAL
2021-03-29
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VX-880
VX-880
Infused into the hepatic portal vein.
Interventions
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VX-880
Infused into the hepatic portal vein.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
* Stable diabetic treatment
* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
University of California San Francisco
San Francisco, California, United States
UHealth Diabetes Research Institute
Miami, Florida, United States
Northwestern Organ Transplant Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Montefiore
Pittsburgh, Pennsylvania, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
VCU Medical Center, Richmond
Richmond, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Alberta, Edmonton
Edmonton, , Canada
McGill University Health Centre
Montreal, , Canada
Toronto General Hospital (TGH)
Toronto, , Canada
Vancouver General Hospital
Vancouver, , Canada
CHU Lille
Lille, , France
Centre de recherche en Biomédecine de Strasbourg
Strasbourg, , France
Dresden Center for Islet Transplantation
Dresden, , Germany
IRCCS Ospedale San Raffaele
Milan, , Italy
Leiden University
Leiden, , Netherlands
Oslo University Hospital
Oslo, , Norway
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
Riyadh, , Saudi Arabia
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
Riyadh, , Saudi Arabia
Hopiteaux Universitaires de Geneve
Geneva, , Switzerland
Churchill Hospital
Headington, Oxford, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Cardiovascular, Metabolic Medicine and Sciences, King's College London
London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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References
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Reichman TW, Markmann JF, Odorico J, Witkowski P, Fung JJ, Wijkstrom M, Kandeel F, de Koning EJP, Peters AL, Mathieu C, Kean LS, Bruinsma BG, Wang C, Mascia M, Sanna B, Marigowda G, Pagliuca F, Melton D, Ricordi C, Rickels MR; VX-880-101 FORWARD Study Group. Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes. N Engl J Med. 2025 Sep 4;393(9):858-868. doi: 10.1056/NEJMoa2506549. Epub 2025 Jun 20.
Other Identifiers
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2024-513929-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
VX20-880-101
Identifier Type: -
Identifier Source: org_study_id
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