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

Part of paid clinical trials in Duarte, California.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT04786262
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • VX-880 — BIOLOGICAL
    Infused into the hepatic portal vein.

Study Details

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.

Key Dates

Start date
Mar 29, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VX-880

Primary Outcome Measure

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) [ Time Frame: From VX-880 infusion to end of study (up to 5 years) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California San FranciscoSan FranciscoCalifornia94143-
UHealth Diabetes Research InstituteMiamiFlorida33136-
Northwestern Organ Transplant CenterChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-
Johns Hopkins UniversityBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical Center MontefiorePittsburghPennsylvania15213-
Baylor Scott and White Research InstituteDallasTexas75246-
VCU Medical Center, RichmondRichmondVirginia23298-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Duarte, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
City of Hope· Duarte, CAUniversity of California San Francisco· San Francisco, CAUHealth Diabetes Research Institute· Miami, FLNorthwestern Organ Transplant Center· Chicago, ILUniversity of Chicago· Chicago, ILJohns Hopkins University· Baltimore, MD

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