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History of Changes for Study: NCT04786262
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
Latest version (submitted August 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 3, 2021 None (earliest Version on record)
2 March 19, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 April 16, 2021 Study Status
4 June 15, 2021 Contacts/Locations and Study Status
5 July 1, 2021 Contacts/Locations and Study Status
6 July 20, 2021 Contacts/Locations and Study Status
7 February 16, 2022 Study Status and Contacts/Locations
8 March 11, 2022 Contacts/Locations and Study Status
9 May 24, 2022 Contacts/Locations, Study Description and Study Status
10 July 26, 2022 Study Description and Study Status
11 August 8, 2022 Contacts/Locations and Study Status
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Study NCT04786262
Submitted Date:  March 3, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: VX20-880-101
Brief Title: A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Not yet recruiting
Study Start: March 2021
Primary Completion: January 2024 [Anticipated]
Study Completion: January 2028 [Anticipated]
First Submitted: March 3, 2021
First Submitted that
Met QC Criteria:
March 3, 2021
First Posted: March 8, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 3, 2021
Last Update Posted: March 8, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Vertex Pharmaceuticals Incorporated
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Diabetes Mellitus, Type 1
Impaired Hypoglycemic Awareness
Severe Hypoglycemia
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 17 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: VX-880 Biological: VX-880
Infused into the hepatic portal vein.
Other Names:
  • Formerly known as STx-02
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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

Open or close this module Contacts/Locations
Central Contact Person: Medical Information
Telephone: 617-341-6777
Email: medicalinfo@vrtx.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
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
Open or close this module References
Citations:
Links:
Available IPD/Information:

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