Trials / Recruiting
RecruitingNCT07457580
Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Teplizumab | This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. |
Timeline
- Start date
- 2026-03-16
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
- First posted
- 2026-03-09
- Last updated
- 2026-04-17
Locations
4 sites across 3 countries: Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07457580. Inclusion in this directory is not an endorsement.