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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
EU CTIS ID: 2024-513929-23-00
What this study is testing
Evaluate the efficacy of VX-880 infusion in subjects who have T1D with impaired hypoglycemic awareness (IAH) and severe hypoglycemia
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinical history and laboratory evidence of T1D
- At least 2 episodes of severe hypoglycemia (confirmed by independent adjudication for subjects in Parts B and C) in the 12 months prior to signing of informed consent at Screening.
- Reduced awareness of hypoglycemia at Screening
- Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening. In regions where CGM is not standard of care for T1D, subjects are exempted from the requirement for use of CGM before Screening.
- Compatible blood group (A or AB)
You likely can't join if
- Prior islet cell transplant, organ transplant, or cell therapy
- Advanced complications associated with diabetes including untreated proliferative retinopathy, skin ulcers, or amputations attributable to diabetes.
- Subjects who have any 1 of the following criteria: o Insulin requirements: >0.8 U/(kg*day), >55 U/day, or <10 U/day; o HbA1c: <6.0% or >9.5%
- Clinically significant active infection or chronic infection such as hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and/or tuberculosis (TB); or invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within 1 year prior to signing of informed consent at Screening.
- Negative screen for Epstein-Barr virus (EBV) by immunoglobulin G (IgG) determination
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom; Switzerland. 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 EU CTIS; the study team decides eligibility.