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Diabetes Mellitus, Type 1

At-Risk for Type 1 Diabetes Extension Study

Sponsored by Provention Bio, Inc.

About this trial

Last updated 2 years ago

Study ID

PRV-031-002

Status

Active, not recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

This study is 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 develop clinical type 1 diabetes after the conclusion of that trial, are eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.

What are the participation requirements?

Yes

Inclusion Criteria

1. Previous participant in the TN-10 study

2. Participant has 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 is able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.

4. Participant is willing to forego other forms of experimental treatment during the entire study.

5. Participant and/or guardian has given informed consent and assent as applicable.

No

Exclusion Criteria

1. Has an active infection and/or fever.

2. Has 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 has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.

Locations

Location

Status