Registry for Stage 2 Type 1 Diabetes

Официальное название

An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Обзор

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D. The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.

Вмешательства

• Препарат TZIELD (teplizumab-mzwv)
  This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Первичные конечные точки

• Number of adverse events of special interests (AESI) [Срок оценки: Throughout the study, approximately 10 years]
• Number of serious adverse events (SAE) [Срок оценки: Throughout the study, approximately 10 years]
• Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy [Срок оценки: From start of pregnancy to 12 months post-partum]
• Number of maternal pregnancy-related events [Срок оценки: From start of pregnancy to 12 months post-partum]
• Developmental outcomes of the infant [Срок оценки: From birth of infant to 12 months]

Критерии участия

Критерии включения

TZIELD-Exposed Cohort

• Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
• Day 1: 65 mcg/m2
• Day 2: 125 mcg/m2
• Day 3: 250 mcg/m2
• Day 4: 500 mcg/m2
• Days 5 through 14: 1,030 mcg/m2 per day
• Cumulative dose is approximately 11,240 mcg/m2
• Appropriate written informed consent/assent as applicable for the age of the patient

TZIELD-Unexposed Cohort

• Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
• Appropriate written informed consent/assent as applicable for the age of the patient

Критерии исключения

• Patients who initiated TZIELD treatment more than 6 months prior to enrollment
• Patients who had participated in a previous clinical trial for TZIELD
• Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 37 центров

• University of California Los Angeles Health- Site Number : 8400020 — Los Angeles
• University of California San Francisco - Mission Bay- Site Number : 8400005 — San Francisco
• University of Colorado Hospital- Site Number : 8400026 — Aurora
• Yale University School of Medicine- Site Number : 8400025 — New Haven
• University of Florida Health- Site Number : 8400035 — Gainesville
• Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006 — Jacksonville
• University of Miami Miller School of Medicine- Site Number : 8400037 — Miami
• Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034 — Miami
• … и ещё 29 центров

Идентификаторы

NCT: NCT06481904 · OBS18117 · U1111-1306-6690

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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