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
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Sponsor:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
Tracking Information | |||||
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First Submitted Date ICMJE | March 3, 2021 | ||||
First Posted Date ICMJE | March 8, 2021 | ||||
Last Update Posted Date | October 31, 2023 | ||||
Actual Study Start Date ICMJE | March 29, 2021 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes | ||||
Official Title ICMJE | 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 | ||||
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 | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: VX-880
Infused into the hepatic portal vein.
Other Name: Formerly known as STx-02
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Study Arms ICMJE | Experimental: VX-880
Intervention: Biological: VX-880
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
17 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | January 2028 | ||||
Estimated Primary Completion Date | January 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, France, Germany, Italy, Netherlands, Norway, Switzerland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04786262 | ||||
Other Study ID Numbers ICMJE | VX20-880-101 2022-002292-11 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Vertex Pharmaceuticals Incorporated | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Vertex Pharmaceuticals Incorporated | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Vertex Pharmaceuticals Incorporated | ||||
Verification Date | February 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |