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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 Key Who Should NOT Join This Trial: -Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: * 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 Key Exclusion Criteria: -Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply

Treatments Being Tested

BIOLOGICAL

VX-880

Infused into the hepatic portal vein.

Locations (20)

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