Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT01106157
Eligibility Criteria:
Inclusion Criteria:
* Must be \> 12 years \< 45
* Must have a diagnosis of T1D of greater than 4 months duration, with an upper limit of 2 years, Now only recruiting for those diagnosed greater than 1 year but less than 2 years.
* Must have at least one diabetes-related autoantibody present (e.g., islet cell autoantigen (ICA), GAD, ZnT8, or islet antigen 2 (IA2) autoantibodies)
* Must have stimulated C-peptide levels ≥ 0.1 pmol/ml (0.3ng/mL) when measured during a mixed meal tolerance test (MMTT), conducted at least 4 months from diagnosis of diabetes, and within 8 weeks of randomization
* Must be EBV PCR negative within two weeks of randomization if EBV seronegative at screening
* Be at least 6 weeks from last live immunization
* Be willing to forgo live vaccines for 3 months following last dose of study drug
* Be willing to comply with intensive diabetes management
* Normal screening values for complete blood count (CBC), renal function and electrolytes (CMP).
Exclusion Criteria:
* Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (\< 3,000 leukocytes /μL), neutropenia (\<1,500 neutrophils/μL), lymphopenia (\<800 lymphocytes/μL), or thrombocytopenia (\<125,000 platelets/μL).
* Have a chronic infection at time of randomization
* Have a positive PPD
* Be currently pregnant or lactating, or anticipate getting pregnant within the next two years
* Require use of other immunosuppressive agents
* Have serologic evidence of current or past HIV, Tuberculosis, Hepatitis B or Hepatitis C infection
* Have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities (e.g., lymphopenia, leukopenia, or thrombocytopenia)
* Have a history of malignancies
* Evidence of liver dysfunction with angiotensin sensitivity test (AST) or ALT greater than 3 times the upper limits of normal
* Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
* Vaccination with a live virus within the last 6 weeks
* Current use of non-insulin pharmaceuticals that affect glycemic control
* Active participation in another T1D treatment study in the previous 30 days
* Known allergy to G-CSF or ATG
* Prior treatment with ATG or known allergy to rabbit derived products
* Any condition that in the investigator's opinion, may adversely affect study participation or may compromise the study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
45 Years
Study:
NCT01106157
Study Brief:
Protocol Section:
NCT01106157