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NCT04786262PHASE3Recruiting

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

Vertex Pharmaceuticals Incorporated

Start Date

3/29/2021

Completion Date

6/30/2030

Summary

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.

Eligibility Criteria

Age Range: 18 years to 65 years

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

Interventions

BIOLOGICAL

VX-880

Interested in This Trial?

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Conditions

Diabetes Mellitus, Type 1Impaired Hypoglycemic AwarenessSevere Hypoglycemia

Locations

City of Hope

Duarte, California 91010

United States

University of California San Francisco

San Francisco, California 94143

United States

UHealth Diabetes Research Institute

Miami, Florida 33136

United States

Northwestern Organ Transplant Center

Chicago, Illinois 60611

United States

University of Chicago

Chicago, Illinois 60637

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center Montefiore

Pittsburgh, Pennsylvania 15213

United States

Baylor Scott and White Research Institute

Dallas, Texas 75246

United States

VCU Medical Center, Richmond

Richmond, Virginia 23298

United States

University of Wisconsin

Madison, Wisconsin 53792

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