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NCT04786262RecruitingPhase 3

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
57 (estimated)
First submitted
3 Mar 2021
Start date
29 Mar 2021
Primary completion date
31 Dec 2027
Lead sponsor
Vertex Pharmaceuticals Incorporated
NCT number
NCT04786262
EU CT number
2024-513929-23-00
EudraCT number
2022-002292-11

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 57
  • From 29 Mar 2021 to the primary completion date, 31 Dec 2027
  • 29 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • -Prior islet cell transplant, organ transplant, or cell therapy

Other

  • Other protocol-defined Inclusion/Exclusion criteria may apply

Who the study is looking for

  • Clinical history of T1D with \>=5 years of duration of insulin dependence
  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alberta Edmonton
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EdmontonCanadaRecruiting
McGill University Health Centre
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MontrealCanadaRecruiting
Toronto General Hospital (TGH)
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TorontoCanadaRecruiting
Vancouver General Hospital
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VancouverCanadaRecruiting
Hopiteaux Universitaires de Geneve
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GenevaSwitzerlandCompleted
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
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DresdenGermanyRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceRecruiting
Royal Infirmary of Edinburgh
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EdinburghUnited KingdomRecruiting
Churchill Hospital
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HeadingtonUnited KingdomRecruiting
Cardiovascular, Metabolic Medicine and Sciences, King's College London
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LondonUnited KingdomRecruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
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Newcastle upon TyneUnited KingdomRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Leiden University Medical Center
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LeidenNetherlandsRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
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RiyadhSaudi ArabiaRecruiting
King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
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RiyadhSaudi ArabiaRecruiting
Johns Hopkins University
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BaltimoreUnited StatesCompleted
Massachusetts General Hospital
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BostonUnited StatesRecruiting
University of Chicago
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ChicagoUnited StatesRecruiting
Northwestern Organ Transplant Center
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ChicagoUnited StatesCompleted
Baylor, Scott and White Research Institute
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DallasUnited StatesRecruiting
City of Hope
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DuarteUnited StatesRecruiting
University of Wisconsin
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MadisonUnited StatesRecruiting
UHealth Diabetes Research Institute
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MiamiUnited StatesRecruiting
Hospital of the University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
University of Pittsburgh Medical Center Montefiore
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PittsburghUnited StatesRecruiting
VCU Medical Center, Richmond
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RichmondUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.