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Tests treatment safety and results for Diabetes Mellitus, Type 1
Official title A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
ClinicalTrials.gov ID: NCT04786262
What this study is testing
What is VX-880?
VX-880 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetes mellitus, type 1.
Also referred to as Zimislecel, Formerly known as STx-02.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- -Prior islet cell transplant, organ transplant, or cell therapy
- Other protocol defined Inclusion/Exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Richmond, Virginia, United States
- Madison, Wisconsin, United States
- Edmonton, Canada
- Montreal, Canada
- Toronto, Canada
- Vancouver, Canada
- Lille, France
- Strasbourg, France
- Dresden, Germany
- Milan, Italy
- Leiden, Netherlands
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Francisco, California, United States; Miami, Florida, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.