At-Risk for Type 1 Diabetes Extension Study
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- STATUS
- Recruiting
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- participants needed
- 30
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- sponsor
- Provention Bio, Inc.
Summary
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.
Description
The study is a single-arm, multicenter, open-label clinical trial. All participants will receive a 12-day course of teplizumab given through daily IV infusion and will be followed for 78 weeks.
The purpose of this study is 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 are able to start teplizumab treatment within 1 year of diagnosis of type 1 diabetes. Whether teplizumab treatment reduces the loss of insulin-producing pancreatic beta cells will also be evaluated.
Details
| Condition | Insulin dependent diabetes mellitus |
|---|---|
| Age | 100 years and younger |
| Treatment | teplizumab |
| Clinical Study Identifier | NCT04270942 |
| Sponsor | Provention Bio, Inc. |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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