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Trial record 1 of 1 for:    VX-880 | Type1diabetes | Florida, United States
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A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04786262
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : February 28, 2023
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Study Description
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Brief Summary:
This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Impaired Hypoglycemic Awareness Severe Hypoglycemia Biological: VX-880 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-880 Biological: VX-880
Infused into the hepatic portal vein.
Other Name: Formerly known as STx-02


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From VX-880 infusion to end of study (up to 5 years) ]
  2. Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline [ Time Frame: At 1 year after VX-880 infusion ]

Secondary Outcome Measures :
  1. Proportion of Participants who are Insulin Independent [ Time Frame: At 1 year after VX-880 infusion ]
  2. Changes in Stimulated C-peptide [ Time Frame: At 1 year after VX-880 infusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Clinical history of T1D with > 5 years of duration
  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04786262


Contacts
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Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Florida
UHealth Diabetes Research Institute Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Northwestern Organ Transplant Center Recruiting
Chicago, Illinois, United States, 60611
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Montefiore Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
VCU Medical Center, Richmond Recruiting
Richmond, Virginia, United States, 23298
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Canada
University of Alberta, Edmonton Recruiting
Edmonton, Canada
McGill University Health Centre Recruiting
Montreal, Canada
Toronto General Hospital (TGH) Recruiting
Toronto, Canada
Vancouver General Hospital Recruiting
Vancouver, Canada
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT04786262    
Other Study ID Numbers: VX20-880-101
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: February 28, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases