Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab

Phase 1

• Conditions: Type 1 Diabetes (T1D); MedDRA version: 20.0Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-002798-92-BE
• Lead Sponsor: Provention Bio, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-03
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

1. 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.
2. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 175
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Premature discontinuation from the PRV-031-001 study for any reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified