EUCTR2022-002292-11-DE
Active, not recruiting
Phase 1
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
ConditionsType 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe HypoglycemiaMedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 21.1Level: LLTClassification code 10081605Term: Severe hypoglycemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 37
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Clinical history and laboratory evidence of T1D
- •2\. At least 2 episodes of severe hypoglycemia (confirmed by independent adjudication for subjects in Parts B and C) in the 12 months prior to signing of informed consent at Screening.
- •3\. Reduced awareness of hypoglycemia at Screening
- •4\. Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening. In regions where CGM is not standard of care for T1D, subjects are exempted from the requirement for use of CGM before Scrreening.
- •5\. Compatible blood group (A or AB)
- •Please refer to Section 8\.1 of the Protocol for additional inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 36
Exclusion Criteria
- •1\. Prior islet cell transplant, organ transplant, or cell therapy
- •2\. Advanced complications associated with diabetes including untreated proliferative retinopathy, skin ulcers, or amputations attributable to diabetes.
- •3\. Subjects who have any 1 of the following criteria:
- •o Insulin requirements: \>0\.8 U/(kg\*day), \>55 U/day, or \<10 U/day;
- •o HbA1c: \<6\.0% or \>9\.5%
- •4\. Clinically significant active infection or chronic infection such as hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and/or tuberculosis (TB); or invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within 1 year prior to signing of informed consent at Screening.
- •5\. Negative screen for Epstein\-Barr virus (EBV) by immunoglobulin G (IgG) determination
- •Please refer to Section 8\.2 of the Protocol for additional exclusion criteria
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Phase 1/2 of Peptide Vaccine S-488210 in Patients with Head and Neck Squamous Cell CarcinomaEUCTR2011-005014-12-DEShionogi & Co., Ltd.92
Active, not recruiting
Phase 1/2
A Safety, Tolerability, and Efficacy Study of VX-264 in Subjects With Type 1 Diabetes2024-515583-32-00Vertex Pharmaceuticals Inc., Vertex Pharmaceuticals Inc.4
Recruiting
Phase 2/3
A Phase 1/2/3 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 Hypoglycemia2024-513929-23-00Vertex Pharmaceuticals Inc.16
Active, not recruiting
Phase 1
A clinical study to evaluate the safety, tolerability, and efficacy of INCB001158 in combination with chemotherapy in subjects with advanced or metastatic solid tumors.EUCTR2017-002904-29-GBIncyte Corporation249
Active, not recruiting
Phase 1
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid TumorsAdvanced Solid TumorsTherapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-002206-52-GBMedImmune1,322