A Phase 1/2 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

Vertex Pharmaceuticals Incorporated0 个研究点目标入组 37 人开始时间: 2022年10月20日最近更新: 2024年7月29日

适应症

试验速览

暂无简介。

•1. Clinical history and laboratory evidence of T1D
•2. 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.
•3. Reduced awareness of hypoglycemia at Screening
•4. 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 Scrreening.
•5. Compatible blood group (A or AB)
•Please refer to Section 8.1 of the Protocol for additional inclusion criteria
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. Prior islet cell transplant, organ transplant, or cell therapy
•2. Advanced complications associated with diabetes including untreated proliferative retinopathy, skin ulcers, or amputations attributable to diabetes.
•3. 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%
•4. 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.
•5. Negative screen for Epstein-Barr virus (EBV) by immunoglobulin G (IgG) determination
•Please refer to Section 8.2 of the Protocol for additional exclusion criteria

发起方