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NCT07061574
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Conditions: Type 1 Diabetes, New Onset
Sex: All
Ages: 9 Years – 20 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 120
Sponsor: City of Hope Medical Center
Location: UCSF San Francisco California
Summary
This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \
Eligibility Criteria
Key Inclusion Criteria:
1. Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.
2. At least one positive T1D auto-antibody.
* If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.
* Insulin auto-antibodies are only considered if exogenous insulin use is \
Source: ClinicalTrials.gov (NCT07061574). StuddyBuddy aggregates publicly available trial information.
