Phase 1 / Phase 2: testing Anti-thymocyte globulin (ATG) for Type 1 Diabetes
This multi-center randomly assigned controlled trial will assess the safety and how well it works of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
Official registry: https://clinicaltrials.gov/study/NCT07061574 · City of Hope Medical Center · enrollment listed as 120
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Anti-thymocyte globulin (ATG), verapamil extended-release capsule, or Adalimumab. The registry lists allocation as randomized. This multi-center randomly assigned controlled trial will assess the safety and how well it works of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.
They plan to enroll about 120 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Interventions: Anti-thymocyte globulin (ATG), verapamil extended-release capsule, Adalimumab
Primary outcome (registry wording): Stimulated C-peptide AUC
Who it is for (from inclusion criteria)
- Ages 9 Years to 20 Years
- Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomly assigned within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit
- 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 \<10 days when blood is drawn
- Must have stimulated C-peptide levels ≥0.2 pmol/mL (≥0.6 ng/mL) measured during MMTT conducted prior to randomization
- Age 9 to \<21 years at the time of randomization
- Body weight \>30kg
Who the registry excludes
- Prior treatment with ATG or known allergy to ATG or rabbit-derived products
- Local lab draw at screening:
- Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\<3,000 leukocytes /μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<800 lymphocytes/μL)
- Thrombocytopenia (\<100,000 platelets/μL) or anemia (hemoglobin \< 10g/dL)
- Leukocytosis (\>14,000/μL)
- Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization
- Have active signs or symptoms of acute infection at the time of randomization
Public study contact (from the registry)
Robert Henderson, MS
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
11 listed- UCLA — Los Angeles, California (not_yet_recruiting)
- UCSF — San Francisco, California (recruiting)
- Yale University — New Haven, Connecticut (recruiting)
- University of Florida — Gainesville, Florida (recruiting)
- University of Miami — Miami, Florida (recruiting)
- Indiana University — Indianapolis, Indiana (recruiting)
- University of Minnesota — Minneapolis, Minnesota (recruiting)
- University of Buffalo — Buffalo, New York (recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania (recruiting)
- Baylor College of Medicine — Houston, Texas (recruiting)
- Seattle Children's Hospital — Seattle, Washington (recruiting)
FAQ about this NCT record
Is NCT07061574 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07061574?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07061574?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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