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

Phase 3RecruitingNCT04786262

Vertex Pharmaceuticals Incorporated52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia

Interventions

VX-880BIOLOGICAL

Infused into the hepatic portal vein.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * 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 Exclusion Criteria: -Prior islet cell transplant, organ transplant, or cell therapy Other protocol defined Inclusion/Exclusion criteria may apply

Locations (29)

Outcomes

Primary Outcomes

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)

Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)

Time frame: 1 year after achieving insulin independence

Secondary Outcomes

Parts B and C: Proportion of Participants who are Insulin Independent

Time frame: At 1 year after VX-880 infusion

Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (<) 7.0%

Time frame: At 1 year after VX-880 infusion

Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: At 1 year after VX-880 infusion

Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year

Time frame: From VX-880 infusion to end of study (up to 5 years)

Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)

Time frame: From Signing of informed consent to end of study (up to 5 years)

Central Contacts

Medical Information

CONTACT

617-341-6777 medicalinfo@vrtx.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

City of Hope

Duarte, California, United States

RECRUITING

University of California San Francisco

San Francisco, California, United States

RECRUITING

UHealth Diabetes Research Institute

Miami, Florida, United States

RECRUITING

Northwestern Organ Transplant Center

Chicago, Illinois, United States

COMPLETED

University of Chicago

Chicago, Illinois, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

University of Pittsburgh Medical Center Montefiore

Pittsburgh, Pennsylvania, United States

RECRUITING

Baylor Scott and White Research Institute

Dallas, Texas, United States

RECRUITING

...and 19 more locations