PROTECT Extension Study
-
StatusAccepting Candidates
-
Age9 Years - 19 Years
-
SexesAll
-
Healthy VolunteersNo
Objective
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.
Description
This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose.
Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study.
No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians.
Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.
Details
Full study title | A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents with Recent-Onset Type 1 Diabetes Mellitus |
Protocol number | OCR41365 |
ClinicalTrials.gov ID | NCT04598893 |
Eligibility
Inclusion Criteria:
Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.
Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.
Exclusion Criteria:
- Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Lead researcher
-
Michael J Haller, MDPediatric Endocrinologist (Child Hormone Specialist)
Participate in a study
Here are some general steps to consider when participating in a research study:
-
Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Michael Haller -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
-
Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
-
Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.