Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
Day 1: 65 mcg/m2
Day 2: 125 mcg/m2
Day 3: 250 mcg/m2
Day 4: 500 mcg/m2
Days 5 through 14: 1,030 mcg/m2 per day
Cumulative dose is approximately 11,240 mcg/m2
Appropriate written informed consent/assent as applicable for the age of the patient
TZIELD-Unexposed Cohort
Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
Appropriate written informed consent/assent as applicable for the age of the patient
You may not be if
Patients who initiated TZIELD treatment more than 6 months prior to enrollment
Patients who had participated in a previous clinical trial for TZIELD
Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
