PROTECT extension: long-term teplizumab safety
What this study tests
Non-interventional extension following participants who completed teplizumab PROTECT to collect longer-term safety and other clinical data over 42 months, per registry.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2025-12-09.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- See registry for full inclusion/exclusion criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted yet.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States, United Kingdom, European Union, Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT04598893: PROTECT extension: long-term teplizumab safety · Trial registry