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 | 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 : October 31, 2023 See Contacts and Locations |
View this study on the modernized ClinicalTrials.gov
Sponsor:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 |
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
| Study Type : | Interventional (Clinical Trial) |
| EstimatedEnrollment : | 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 
MedlinePlus Genetics related topics: Type1diabetes
MedlinePlus related topics: DiabetesType1 Hypoglycemia
U.S. FDA Resources
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
| Arm | Intervention/treatment |
|---|---|
| Experimental: VX-880 | Biological: VX-880 Infused into the hepatic portal vein. Other Name: Formerly known as STx-02 |
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Primary Outcome Measures :
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [TimeFrame:From VX-880 infusion to end of study (up to 5 years)]
- Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycosylated Hemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in HbA1c From Baseline [TimeFrame:At 1 year after VX-880 infusion]
Secondary Outcome Measures :
- Proportion of Participants who are Insulin Independent [TimeFrame:At 1 year after VX-880 infusion]
- Changes in Stimulated C-peptide [TimeFrame:At 1 year after VX-880 infusion]
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
| Contact: Medical Information | 617-341-6777 | medicalinfo@vrtx.com |
Locations
Show 22 study locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
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Top of Page Study Description Study Design
Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Diabetes Mellitus Diabetes Mellitus, Type 1 Hypoglycemia Glucose Metabolism Disorders | Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
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