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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2024-01-22

Brief Summary

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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.

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Detailed Description

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The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks.

The purpose of this study was to evaluate the safety and tolerability of teplizumab treatment, administered intravenously (IV) to participants in the NIH-sponsored trial who have developed type 1 diabetes and were able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduced the loss of insulin-producing pancreatic beta cells were evaluated.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm, multicenter, open-label clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teplizumab treated

Administration of teplizumab by intravenous infusion for 12 consecutive days

Group Type EXPERIMENTAL

teplizumab 1 mg/mL

Intervention Type DRUG

Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody).

Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily

Interventions

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teplizumab 1 mg/mL

Solution for infusion administered as IV infusion (anti-CD3 humanized monoclonal antibody).

Cumulative dose: 9 mg/m2. Day 1: 106 μg/m2, Day 2: 425 μg/m2, Days 3-12: 850 μg/m2 daily

Intervention Type DRUG

Other Intervention Names

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PRV-031, Tzield

Eligibility Criteria

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Inclusion Criteria

1. Previous participant in the TN-10 study
2. Participant had received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA).
3. Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
4. Participant was willing to forego other forms of experimental treatment during the entire study.
5. Participant and/or guardian had given informed consent and assent as applicable.

Exclusion Criteria

1. Had an active infection and/or fever.
2. Had a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
3. An individual who had a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.

Eligible Sex

ALL

Accepts Healthy Volunteers

No