RECRUITING

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

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Conditions

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-29
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04786262

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical history of T1D with \> 5 years of duration of insulin dependence
  2. * At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment
  3. * Stable diabetic treatment
  4. * 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
  1. * Prior islet cell transplant, organ transplant, or cell therapy

Contacts and Locations

Study Contact

Medical Information
CONTACT
617-341-6777
medicalinfo@vrtx.com

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
UHealth Diabetes Research Institute
Miami, Florida, 33136
United States
Northwestern Organ Transplant Center
Chicago, Illinois, 60611
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
VCU Medical Center, Richmond
Richmond, Virginia, 23298
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Vertex Pharmaceuticals Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-29
Study Completion Date2030-06

Study Record Updates

Study Start Date2021-03-29
Study Completion Date2030-06

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1
  • Impaired Hypoglycemic Awareness
  • Severe Hypoglycemia