RecruitingPhase 3NCT04786262

A Safety, Tolerability, and Efficacy Study of VX-880 and VX-017 in Participants With Type 1 Diabetes

A Master Protocol to Evaluate the Safety, Tolerability, and Efficacy of Islet Cell Replacement Therapies in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia: A Phase 1/2/3 Study of VX-880 and a Phase 1/2 Study of VX-017

Sponsor

Vertex Pharmaceuticals Incorporated

Enrollment

57 participants

Start Date

Mar 29, 2021

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia

Summary

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion and VX-017 infusion in participants with type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing VX-880, a new cell therapy for people with Type 1 diabetes. Type 1 diabetes happens when the immune system destroys insulin-producing cells in the pancreas. VX-880 aims to replace those cells. This study is checking whether the treatment is safe and whether it can help the body produce insulin again. **You may be eligible if...** - You have had Type 1 diabetes for more than 5 years and have been dependent on insulin the whole time - You have had at least two severe low blood sugar episodes in the past year - You have been using a continuous glucose monitor (CGM) for at least 3 months and are willing to keep using it - Your diabetes treatment has been stable **You may NOT be eligible if...** - You have previously had an islet cell transplant, organ transplant, or other cell therapy - You do not meet other protocol-defined health criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVX-880

Infused into the hepatic portal vein.

BIOLOGICALVX-017

Infused into the hepatic portal vein.

Locations(29)

City of Hope

Duarte, California, United States

University of California San Francisco

San Francisco, California, United States

UHealth Diabetes Research Institute

Miami, Florida, United States

Northwestern Organ Transplant Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Montefiore

Pittsburgh, Pennsylvania, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

VCU Medical Center, Richmond

Richmond, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

University of Alberta, Edmonton

Edmonton, Canada

McGill University Health Centre

Montreal, Canada

Toronto General Hospital (TGH)

Toronto, Canada

Vancouver General Hospital

Vancouver, Canada

CHU Lille

Lille, France

Centre de recherche en Biomédecine de Strasbourg

Strasbourg, France

Dresden Center for Islet Transplantation

Dresden, Germany

IRCCS Ospedale San Raffaele

Milan, Italy

Leiden University

Leiden, Netherlands

Oslo University Hospital

Oslo, Norway

King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology

Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology

Riyadh, Saudi Arabia

Hopiteaux Universitaires de Geneve

Geneva, Switzerland

Churchill Hospital

Headington, Oxford, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Cardiovascular, Metabolic Medicine and Sciences, King's College London

London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04786262

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