Actively Recruiting

All Genders
NCT07457580

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

Led by Sanofi · Updated on 2026-04-17

60

Participants Needed

4

Research Sites

37 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient provided written or electronic informed consent or assent (if under 18) according to local rules before any study activity
  • Patient received at least 1 day of teplizumab treatment as part of Managed Access Programs (MAPs)
Not Eligible

You will not qualify if you...

  • Participation in an interventional clinical study on the index date, defined as starting the product or procedure under investigation that deviates from standard clinical practice

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Investigational Site Number: 3800003

Palermo, Italy, 90127

Actively Recruiting

2

Investigational Site Number: 7240001

Madrid, Spain, 28034

Actively Recruiting

3

Investigational Site Number: 7240002

Madrid, Spain, 28046

Actively Recruiting

4

Investigational Site Number: 8260002

London, United Kingdom, E1 1BB

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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