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Completed Phase 2 Interventional Results available

At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

ClinicalTrials.gov ID: NCT04270942

Public ClinicalTrials.gov record NCT04270942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

Study identification

NCT ID
NCT04270942
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
6 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 26, 2020 (Actual)
Primary completion
Jan 22, 2024 (Actual)
Completion
Jan 22, 2024 (Actual)
Last update posted
Feb 12, 2025

2020 – 2024

United States locations

U.S. sites
8
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Barbara Davis Center for Diabetes Site Number : 04 Aurora Colorado 80045 —
Clinical Site Aurora Colorado 80045 —
Yale University School of Medicine Site Number : 01 New Haven Connecticut 06511 —
Clinical Site New Haven Connecticut 06519 —
Clinical Site Gainesville Florida 32610 —
University of Florida Site Number : 02 Gainesville Florida 32610 —
Clinical Site Nashville Tennessee 37232 —
Vanderbilt Univerity Medical Center Site Number : 03 Nashville Tennessee 37232 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04270942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 12, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04270942 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →