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

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ClinicalTrials.gov Identifier: NCT04786262
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : October 31, 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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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
2022-002292-11 ( EudraCT Number )
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: October 31, 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