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Recruiting NCT07457580

Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

Conditions: Type 1 Diabetes

Sponsor: Sanofi

trial.available_in: БГ
Overview
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
Who can participate
Inclusion Criteria: * Patient written or electronic informed consent or assent (for patients \< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity. * Patient received ≥ 1 day of teplizumab treatment as part of MAPs. Exclusion Criteria: • Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Interventions
Teplizumab
DRUG
Locations 4
Italy (1)
Investigational Site Number: 3800003
Palermo
Spain (2)
Investigational Site Number: 7240001
Madrid
Investigational Site Number: 7240002
Madrid
United Kingdom (1)
Investigational Site Number: 8260002
London
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
16.03.2026
Completion date
30.11.2026
Registry ID
NCT07457580
Source
clinicaltrials.gov
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