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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513929-23-00 | Other Identifier | EU Trial (CTIS) Number |
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This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-880 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-880 | Biological | Infused into the hepatic portal vein. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) | From VX-880 infusion to end of study (up to 5 years) | |
| Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs) | 1 year after achieving insulin independence |
| Measure | Description | Time Frame |
|---|---|---|
| Parts B and C: Proportion of Participants who are Insulin Independent | At 1 year after VX-880 infusion | |
| Parts B and C: Proportion of Participants Free from SHEs with a Glycosylated Hemoglobin (HbA1c) less than (<) 7.0% | At 1 year after VX-880 infusion |
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Key Inclusion Criteria:
Key Exclusion Criteria:
-Prior islet cell transplant, organ transplant, or cell therapy
Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 617-341-6777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40544428 | Derived | Reichman TW, Markmann JF, Odorico J, Witkowski P, Fung JJ, Wijkstrom M, Kandeel F, de Koning EJP, Peters AL, Mathieu C, Kean LS, Bruinsma BG, Wang C, Mascia M, Sanna B, Marigowda G, Pagliuca F, Melton D, Ricordi C, Rickels MR; VX-880-101 FORWARD Study Group. Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes. N Engl J Med. 2025 Sep 4;393(9):858-868. doi: 10.1056/NEJMoa2506549. Epub 2025 Jun 20. |
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Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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| Parts B and C: Change From Baseline in Glycosylated Hemoglobin (HbA1c) | At 1 year after VX-880 infusion |
| Parts B and C: Proportion of Participants Who Maintain Insulin Independence for at least 1 year | From VX-880 infusion to end of study (up to 5 years) |
| Parts B and C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) | From Signing of informed consent to end of study (up to 5 years) |
| Recruiting |
| San Francisco |
| California |
| 94143 |
| United States |
| UHealth Diabetes Research Institute | Recruiting | Miami | Florida | 33136 | United States |
| Northwestern Organ Transplant Center | Completed | Chicago | Illinois | 60611 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center Montefiore | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor Scott and White Research Institute | Recruiting | Dallas | Texas | 75246 | United States |
| VCU Medical Center, Richmond | Recruiting | Richmond | Virginia | 23298 | United States |
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53792 | United States |
| 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 |
| CHU Lille | Recruiting | Lille | France |
| Centre de recherche en Biomédecine de Strasbourg | Recruiting | Strasbourg | France |
| Dresden Center for Islet Transplantation | Recruiting | Dresden | Germany |
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Italy |
| Leiden University | Recruiting | Leiden | Netherlands |
| Oslo University Hospital | Recruiting | Oslo | Norway |
| King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology | Recruiting | Riyadh | Saudi Arabia |
| King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology | Recruiting | Riyadh | Saudi Arabia |
| Hopiteaux Universitaires de Geneve | Completed | Geneva | Switzerland |
| Churchill Hospital | Recruiting | Headington | Oxford | United Kingdom |
| Royal Infirmary of Edinburgh | Recruiting | Edinburgh | United Kingdom |
| Cardiovascular, Metabolic Medicine and Sciences, King's College London | Recruiting | London | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Recruiting | Newcastle upon Tyne | United Kingdom |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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